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10/24/2014 510(k) Clearances > April 2014 510(k) Clearances

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April 2014 510(k) Clearances510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD April 2014 DEVICE: OMNYX IDP FOR HER2 MANUAL APPLICATIONOMNYX, LLC 510(k) NO: K1311401(TRADITIONAL)ATTN: GAIL E RADCLIFFE PHONE NO : 508 835 1688 62 FOREST STREET, SUITE 300 SE DECISION MADE: 01-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A1C GEAR SYSTEMSAKAE CORPORATION 510(k) NO: K1300142(TRADITIONAL)ATTN: ERICA B AMMIRATI PHONE NO : 650 949 2768 575 SHIRLYNN COURT SE DECISION MADE: 04-APR-14LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTUS C. DIFFICILE QS-RGQ MDX KITQIAGEN, GMBH 510(k) NO: K1339363(TRADITIONAL)ATTN: KIMBERLY MAPP PHONE NO : 301 944 7817 1201 CLOPPER RD SE DECISION MADE: 04-APR-14GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WUNDER PREGNANCY TESTJAMES NGUYEN 510(k) NO: K1304564(TRADITIONAL)ATTN: JAMES NGUYEN, M.D. PHONE NO : 408 569 5454 2231 FORTUNE DR, STE D SE DECISION MADE: 08-APR-14SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K1400895(TRADITIONAL)ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 08-APR-14GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEMLK CONSULTING GROUP USA, INC. 510(k) NO: K1330456(TRADITIONAL)ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-APR-14FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREELITE HUMAN LAMBDA FREE KITTHE BINDING SITE GROUP, LTD. 510(k) NO: K1403967(TRADITIONAL)ATTN: DOUG KURTH PHONE NO : 5889 OBDERLIN DR., STE 101 SE DECISION MADE: 16-APR-14SAN DIEGO CA 92121 510(k) STATEMENT DEVICE: HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUSTHE BINDING SITE GROUP, LTD. 510(k) NO: K1406648(TRADITIONAL)ATTN: JON LAUDER PHONE NO : 44 121 45695008 CALTHORPE ROAD SE DECISION MADE: 16-APR-14EDGBASTON UK B15 1QT 510(k) STATEMENT DEVICE: ELEMENTV BLOOD GLUCOSE MONITORING SYSTEMINFOPIA CO., LTD 510(k) NO: K1324069(TRADITIONAL)ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 18-APR-14FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEMEPS BIO TECHNOLOGY CORP. 510(k) NO: K13353710(SPECIAL)ATTN: CYNTHIA HUNG PHONE NO : 886 36 686868X652NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 28-APR-14HSINCHU CITY, TW 30077 510(k) STATEMENT DEVICE: VUPADSONOMED, INC. 510(k) NO: K14019911(TRADITIONAL)

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ATTN: CHARLES C O'NEAL PHONE NO : 516 354 0900 1979 MARCUS AVE., SUITE 105C SE DECISION MADE: 01-APR-14LAKE SUCCESS NY 11042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VADO STEERABLE SHEATHKALILA MEDICAL, INC. 510(k) NO: K14042012(TRADITIONAL)ATTN: CARRIE NEUBERGER PHONE NO : 415 640 3377 745 CAMDEN AVE, SUITE A SE DECISION MADE: 01-APR-14CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE CSIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K14054113(ABBREVIATED)ATTN: GARO MIMARYAN PHONE NO : 914 524 3270 511 BENEDICT AVE. SE DECISION MADE: 01-APR-14TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED DISTAL RADIUS PLATING SYSTEMBIOMET 510(k) NO: K13393914(TRADITIONAL)ATTN: SUZANA OTANO PHONE NO : 305 269 6386 56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 01-APR-14WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX CLAVICLE HOOK PLATESTRYKER TRAUMA AG 510(k) NO: K14025915(TRADITIONAL)ATTN: ELIJAH N WREH PHONE NO : 201 831 5691 325 CORPORATE DRIVE SE DECISION MADE: 01-APR-14MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABLET VIEWER SOFTWARE FOR IMAGE SUITECARESTREAM HEALTH, INC. 510(k) NO: K14027116(TRADITIONAL)ATTN: ALEXANDRA CHAMBERLAIN PHONE NO : 585 627 8790 150 VERONA STREET SE DECISION MADE: 01-APR-14ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMBIBE NEEDLEORTHOVITA, INC. 510(k) NO: K14041417(TRADITIONAL)ATTN: JOHN URTZ PHONE NO : 610 407 7450 77 GREAT VALLEY PARKWAY SE DECISION MADE: 01-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILLARTHROCARE CORPORATION 510(k) NO: K13360618(TRADITIONAL)ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995 7000 West William Cannon Drive SE DECISION MADE: 01-APR-14Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNESIS PEEK CERVICAL CAGEBK MEDITECH CO., LTD. 510(k) NO: K13248319(TRADITIONAL)ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 PO BOX 560 SE DECISION MADE: 02-APR-14STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AHP 300, EMERGENCY PORTABLE VENTILATORALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K13202120(TRADITIONAL)ATTN: STEPHEN MUNDWILLER PHONE NO : 314 268 1661 1720 SUBLETTE AVE. SE DECISION MADE: 02-APR-14Saint Louis MO 63110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNATURE PLANNER, SIGNATURE GUIDESMATERIALISE N.V. 510(k) NO: K14025721(TRADITIONAL)ATTN: OLIVER CLEMENS PHONE NO : 321 674453 715 TECHNOLOGIELAAN SE DECISION MADE: 02-APR-14LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETERBOSTON SCIENTIFIC CORPORATION 510(k) NO: K13393322(SPECIAL)ATTN: ASHLEY SANTOS PHONE NO : 508 683 4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 02-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35XDIALYSIS MEDICAL SOLUTIONS, LLC 510(k) NO: K13120223(TRADITIONAL)ATTN: COURTNEY J MILLER PHONE NO : 614 719 2858 21 EAST STATE STREET SUITE 1700 SE DECISION MADE: 03-APR-14COLUMBUS OH 43215 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SETSPENCER FILLMORE 510(k) NO: K13075724(TRADITIONAL)ATTN: CHRISTINA BERNSTEIN PHONE NO : 415 450 0515 2670 LEAVENWORTH ST. SE DECISION MADE: 03-APR-14SAN FRANCISCO CA 94133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIZION ULTRAVIZTEK LLC 510(k) NO: K13313925(SPECIAL)ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 03-APR-14NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIBLE COOAGEN NERVE CUFFCOLLAGEN MATRIX, INC. 510(k) NO: K13154126(TRADITIONAL)ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 15 THORNTON ROAD SE DECISION MADE: 03-APR-14OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY PRO LEAD DELIVERY SYSTEMBOSTON SCIENTIFIC 510(k) NO: K13291427(TRADITIONAL)ATTN: HOLLY RAMIREZ PHONE NO : 763 494 2113 ONE SCIMED PLACE SE DECISION MADE: 03-APR-14MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL CODE WRITERZOLL MEDICAL CORPORATION 510(k) NO: K13248828(TRADITIONAL)ATTN: SHANNON DUHAMEL PHONE NO : 978 421 9574 269 MILL ROAD SE DECISION MADE: 03-APR-14CHELMSFORD MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCLOT TOPICALCRYOLIFE, INC. 510(k) NO: K13210529(TRADITIONAL)ATTN: KIMBERLY DICONO PHONE NO : 770 419 3355 1655 ROBERTS BLVD., N.W. SE DECISION MADE: 03-APR-14KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSOURCE IV ADMINISTRATION SET 72" MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SETMEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K14040230(SPECIAL)ATTN: JENNIFER NESS PHONE NO : 952 241 8318 5346 SHORELINE DR. SE DECISION MADE: 03-APR-14MOUND MN 55364 510(k) STATEMENT DEVICE: COROENT SMALL INTERBODY SYSTEMNUVASIVE, INC. 510(k) NO: K14000331(TRADITIONAL)ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BLVD SE DECISION MADE: 03-APR-14SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEUTIAN IBF SYSTEMK2M, INC. 510(k) NO: K13361432(TRADITIONAL)ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR SE SE DECISION MADE: 03-APR-14LEESBURG VA 22066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEADMICROPORT ORTHOPEDICS INC. 510(k) NO: K14004333(TRADITIONAL)ATTN: MAX MORTENSEN PHONE NO : 901 485 1102 5677 AIRLINE RD SE DECISION MADE: 03-APR-14Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLEMEDCOM GMBH 510(k) NO: K13391434(ABBREVIATED)ATTN: LUCA SALVATORE PHONE NO : 49 6151 9514718RUNDETURMSTRASSE 12 SE DECISION MADE: 03-APR-14DARMSTADT GM 64283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY GLOBAL UNITE SHOULDER SYSTEMDEPUY (IRELAND) 510(k) NO: K13383435(TRADITIONAL)ATTN: KELLIE MYERS PHONE NO : 574 372 7276LOUGHBEG RINGASKIDDY SE DECISION MADE: 03-APR-14CO. CORK EI IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUB-Q SUBCUTANEOUS TISSUE INFUSION SETEMED TECHNOLOGIES CORPORATION 510(k) NO: K14013136(SPECIAL)
















ATTN: PETER KOLLINGS PHONE NO : 916 932 0071 1264 Hawks Flight Ct Ste 200 SE DECISION MADE: 03-APR-14EL DORADO HILLS CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALCONNECT PLATFORM BY VITAL CONNECT INC.VITAL CONNECTIONS, INC. 510(k) NO: K13244737(TRADITIONAL)ATTN: SAM MOSTAFAVI PHONE NO : 408 963 4620 900 E. HAMILTON AVE. STE # 500 SE DECISION MADE: 03-APR-14CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOTOP(R) SCKITAZATO BIOPHARMA CO., LTD. 510(k) NO: K14007238(TRADITIONAL)ATTN: RICHARD VINCINS PHONE NO : 512 327 9997 816 CONGRESS AVE SUITE 1400 SE DECISION MADE: 03-APR-14AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACH LED 2SCDR. MACH GMBH & CO. KG 510(k) NO: K14046039(SPECIAL)ATTN: GUDRUN BUSCH, PH.D. PHONE NO : 49 40 58979794FEHMARNSTRASSE 31 SE DECISION MADE: 03-APR-14NORDERSTEDT, SCHLESWIG-HOLSTEIN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACH LED 2MCDR. MACH GMBH & CO. KG 510(k) NO: K14046140(SPECIAL)ATTN: GUDRUN BUSCH, PH.D. PHONE NO : 49 40 58979794FEHMARNSTRASSE 31 SE DECISION MADE: 03-APR-14NORDERSTEDT, SCHLESWIG-HOLSTEIN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX 2 SYSTEMSTRYKER TRAUMA AG 510(k) NO: K14037641(TRADITIONAL)ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 03-APR-14MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOUDEKGMAKROMED, INC. 510(k) NO: K13087842(TRADITIONAL)ATTN: BARRY V ASHAR PHONE NO : 603 890 3311 88 STILES ROAD SE DECISION MADE: 04-APR-14SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREWIN2BONES SAS 510(k) NO: K13291143(TRADITIONAL)ATTN: ERIC FOURCAULT PHONE NO : 28 CHEMIN DU PETIT BOIS 69130 ECULSE DECISION MADE: 04-APR-14FRANCE FR 69130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMRI HELIOS-RG8 COIL ACCESSORY KITCLEARMRI SOLUTIONS, INC. 510(k) NO: K13238144(TRADITIONAL)ATTN: MARY ANN FERGUSON PHONE NO : 978 578 1196 W315 S3283 Harvest View Drive SE DECISION MADE: 04-APR-14Waukesha WI 53189 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 8MP COLOR LCD MONITOR, RADIFORCE RX850EIZO CORPORATION 510(k) NO: K14070245(TRADITIONAL)ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468153 SHIMOKASHIWANO SE DECISION MADE: 04-APR-14HAKUSAN JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACENOBEL BIOCARE AB 510(k) NO: K13337746(TRADITIONAL)ATTN: PHUONG NGUYEN PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 04-APR-14YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORDICBRAINEXNORDICNEUROLAB 510(k) NO: K13391047(TRADITIONAL)ATTN: CHANDANA GURUNG BHANDARI PHONE NO : 475 57 07095MOLLENDALSVEIEN 65C SE DECISION MADE: 04-APR-14BERGEN NO N-5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: US ENDOSCOPY DISTAL ATTACHMENT CAPUNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K14031548(TRADITIONAL)ATTN: SAGAR D PIMPALWAR PHONE NO : 440 639 4494 5976 HEISLEY RD. SE DECISION MADE: 04-APR-14















MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GELBIOPLAX LIMITED 510(k) NO: K13095949(TRADITIONAL)ATTN: PAUL KETTERIDGE PHONE NO : 443 729 0836 472 S STATE STREET, #101 SE DECISION MADE: 04-APR-14BELLINGHAM WA 98225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSP HIP FRACTURE PLATING SYSTEMBIOMET, INC. 510(k) NO: K14001850(TRADITIONAL)ATTN: GARY BAKER PHONE NO : 574 267 6639 56 EAST BELL DR. SE DECISION MADE: 04-APR-14WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHORTORNIER, INC. 510(k) NO: K13377751(TRADITIONAL)ATTN: MIREILLE LEMERY PHONE NO : 10801 NESBITT AVENUE SOUTH SE DECISION MADE: 04-APR-14BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIBALL INCENTIVE SPIROMETERBESMED HEALTH BUSINESS CORP. 510(k) NO: K13387352(TRADITIONAL)ATTN: PAUL DRYDEN PHONE NO : 239 498 2155NO.5, LANE116, WU-KONG 2ND RD SE DECISION MADE: 04-APR-14NEW TAIPEI CITY, WU-KU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIA RADIATION THERAPY MANAGEMENTVARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K13357253(TRADITIONAL)ATTN: PETER J CORONADO PHONE NO : 650 424 5731 3120 HANSEN WAY C-260 SE DECISION MADE: 04-APR-14PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD RITECATH INTERMITTENT CATHETERC.R. BARD, INC. 510(k) NO: K13347054(TRADITIONAL)ATTN: MICHELE DAVIS PHONE NO : 770 784 6274 8195 INDUSTRIAL BLVD SE DECISION MADE: 04-APR-14COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO DUAL ENERGY SOFTWARE PACKAGESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K13290255(TRADITIONAL)ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PKWY. SE DECISION MADE: 07-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROPHILIC COATED GUIDEWIRELAKE REGION MEDICAL 510(k) NO: K13315556(TRADITIONAL)ATTN: TRACY MEYER PHONE NO : 952 448 5111 340 LAKE HAZELTINE DRIVE SE DECISION MADE: 07-APR-14CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THREADED PEEK K-WIREMTP SOLUTIONS LLC 510(k) NO: K13323557(TRADITIONAL)ATTN: ROBERT HOY PHONE NO : 614 448 6358 124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 07-APR-14LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDINAUT KYPHOPLASTY SYSTEMIMEDICOM 510(k) NO: K13366958(TRADITIONAL)ATTN: PRISCILLA CHUNG PHONE NO : 714 922 5276 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 07-APR-14FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEED TRIADBIOMEDICAL ENT., INC. 510(k) NO: K13384459(SPECIAL)ATTN: JOE SOWARD PHONE NO : 210 677 0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 07-APR-14SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0MERETE MEDICAL GMBH 510(k) NO: K14006960(TRADITIONAL)ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 493 077998 0114102 ALT LANKWITZ SE DECISION MADE: 07-APR-14BERLIN GM D-12247 510(k) STATEMENT DEVICE: FRAGMENT PLATE SYSTEM















SKELETAL DYNAMICS, LLC 510(k) NO: K14037261(TRADITIONAL)ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 07-APR-14MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABACUS TM SPACER SYSTEMSPINE WAVE, INC. 510(k) NO: K14000762(TRADITIONAL)ATTN: JOSEPH MERCADO PHONE NO : 203 944 9494 THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 07-APR-14SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXANO SURGICAL MIS SPINAL SYSTEMBAXANO SURGICAL, INC. 510(k) NO: K13374363(TRADITIONAL)ATTN: KRISTEN ALLEN PHONE NO : 910 332 1733 301 Government Center Drive SE DECISION MADE: 07-APR-14Wilmington NC 28403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAFUSEBAXTER HEALTHCARE CORP. 510(k) NO: K13053164(TRADITIONAL)ATTN: GRETCHEN MURRAY PHONE NO : 805 372 3065 ONE BAXTER WAY SE DECISION MADE: 08-APR-14WESTLAKE VILLAGE CA 91362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT 60 VENTILATORFLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K13017165(TRADITIONAL)ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 JN PEASE PLACE SE DECISION MADE: 08-APR-14CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE GYNOCULARGYNIUS AB 510(k) NO: K13242366(TRADITIONAL)ATTN: MATTHEW VOLSKY PHONE NO : 46 700 237670DOBELNSGATAN 23 SE DECISION MADE: 08-APR-14STOCKHOLM SW 11140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANDREL GUIDEWIRELAKE REGION MEDICAL 510(k) NO: K14048267(SPECIAL)ATTN: MATHEW PEXA PHONE NO : 952 488 5111 340 LAKE HAZELTINE DRIVE SE DECISION MADE: 08-APR-14CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGSTOP CALIBRE SDN BHD 510(k) NO: K13394968(TRADITIONAL)ATTN: ROSNITA MAODIN PHONE NO : 603 329105 16Lot 13726, Jalan Haji Salleh, BatuSE DECISION MADE: 08-APR-14KLANG, SELANGOR MY 41050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL LIGHT HANDLE COVERMICROTEK MEDICAL, INC. AN ECOLAB C510(k) NO: K13355469(SPECIAL)ATTN: ANDY ROLLER PHONE NO : 651 293 2080 370 WABASHA STREET N SE DECISION MADE: 08-APR-14ST. PAUL MN 55102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHROS POSTERIOR STABILIZATION SYSTEMCAMBER SPINE 510(k) NO: K13336670(TRADITIONAL)ATTN: DANIEL A PONTECORVO PHONE NO : 484 420 4671 90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 08-APR-14NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGYCOVIDIEN 510(k) NO: K12355571(TRADITIONAL)ATTN: JIM WELSH PHONE NO : 508 261 8532 15 HAMPSHIRE STREET SE DECISION MADE: 09-APR-14MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA ISQOSSTELL AB 510(k) NO: K13240172(SPECIAL)ATTN: CHERITA JAMES PHONE NO : 703 562 9800 901 KING STREET SUITE 101 SE DECISION MADE: 09-APR-14ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZELTIQ COOLSCULPTING SYSTEMZELTIQ AESTHETICS, INC. 510(k) NO: K13321273(TRADITIONAL)ATTN: SHRUTI JAYAKUMAR PHONE NO : 925 621 2516 4698 Willow Road SE DECISION MADE: 09-APR-14
















Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEMOPUS KSD, INC. 510(k) NO: K13156374(TRADITIONAL)ATTN: ROSINA ROBINSON, RN, MED, RPHONE NO : 508 247 7244 62 FOREST STREET SUITE 300 SE DECISION MADE: 09-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER TEMPORARY CONDYLAR PROSTHESISSTRYKER 510(k) NO: K13328575(TRADITIONAL)ATTN: JAMSHED BADARPURA PHONE NO : 269 389 4260 750 TRADE CENTRE WAY STE 200 SE DECISION MADE: 09-APR-14PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HTFX-222GC AMERICA, INC. 510(k) NO: K13318276(TRADITIONAL)ATTN: MARK HEISS PHONE NO : 708 597 0900 3737 WEST 127TH ST. SE DECISION MADE: 09-APR-14ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTAX VIDEO COLONOSCOPES (EC FAMILY)PENTAX MEDICAL COMPANY 510(k) NO: K13185577(TRADITIONAL)ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880 3 Paragon Drive SE DECISION MADE: 09-APR-14MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMERGENCY PORTABLE VENTILATORALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K13109878(TRADITIONAL)ATTN: STEPHEN MUNDWILLER PHONE NO : 314 268 1661 1720 SUBLETTE AVE. SE DECISION MADE: 09-APR-14ST LOUIS MO 63110 510(k) STATEMENT DEVICE: MD-FLEX HEAVY BODYMETA BIOMED, INC. 510(k) NO: K13400879(TRADITIONAL)ATTN: BLIX WINSTON PHONE NO : 301 607 9185 2600 MULLINIX MILL ROAD SE DECISION MADE: 09-APR-14MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMOS VIDEO NASOPHARYNGOSCOPE SYSTEMSCHOELLY FIBEROPTIC, GMBH 510(k) NO: K13200980(TRADITIONAL)ATTN: PAMELA PAPINEAU, RAC PHONE NO : 978 772 3552 5 WHITCOMB AVE. SE DECISION MADE: 09-APR-14AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEXICONTURE MECHANICAL DILATOR SHEATH SETSPECTRANETICS CORP. 510(k) NO: K14004781(TRADITIONAL)ATTN: PHAROAH GARMA PHONE NO : 719 447 2385 9665 FEDERAL DRIVE SE DECISION MADE: 09-APR-14COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRC-PASTEKM CORPORATION 510(k) NO: K13371682(TRADITIONAL)ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 1515 E. KATELLA AVE UNIT 2115 SE DECISION MADE: 09-APR-14ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIORA V-TOTALVIORA LTD. 510(k) NO: K13383783(TRADITIONAL)ATTN: YORAM LEVY PHONE NO : 972 4 638883731 HAAVODA ST. SE DECISION MADE: 09-APR-14BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKSCOVIDIEN 510(k) NO: K14060984(SPECIAL)ATTN: CLARE SANTULLI PHONE NO : 203 492 7635 60 MIDDLETOWN AVE SE DECISION MADE: 09-APR-14NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIX SELECT DRSIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K13293485(TRADITIONAL)ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PARKWAY SE DECISION MADE: 10-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IEEG















JORDAN NEUROSCIENCE, INC. 510(k) NO: K13194486(TRADITIONAL)ATTN: ANNE PERRY PHONE NO : 909 881 2694 1660 PLUM LANE SE DECISION MADE: 10-APR-14REDLANDS CA 92374 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)PENTAX MEDICAL COMPANY 510(k) NO: K13190287(TRADITIONAL)ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880 3 Paragon Drive SE DECISION MADE: 10-APR-14MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR I V3.1 SYSTEMSYNERON MEDICAL LTD 510(k) NO: K13323888(TRADITIONAL)ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 10-APR-14PHILADELPHIA PA 19103 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESMATERIALISE N.V. 510(k) NO: K13229089(TRADITIONAL)ATTN: OLIVER CLEMENS PHONE NO : 32 16 744537TECHNOLOGIELAAN 15 SE DECISION MADE: 10-APR-14LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA NEO CLINICAL THERAPY SYSTEMDJO, LLC 510(k) NO: K13228490(TRADITIONAL)ATTN: MARIA PRONINA PHONE NO : 760 734 5599 1430 Decision St SE DECISION MADE: 10-APR-14VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STREAMLINE TL SPINAL FIXATION SYSTEMPIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K14069691(SPECIAL)ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861 375 RIVER PARK CIRCLE SE DECISION MADE: 10-APR-14Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUALGUARDFLEXICARE MEDICAL LTD. 510(k) NO: K14047392(TRADITIONAL)ATTN: CHRISTOPHER WATKINS PHONE NO : 441 44 3471593CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 10-APR-14MID GLAMORGAN UK CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIO-PROBE TRANSDUCER (ADULT)MEDTRONIC INC. 510(k) NO: K13390393(TRADITIONAL)ATTN: RAHUL SHAH PHONE NO : 763 514 9846 8200 CORAL SEA STREET NE SE DECISION MADE: 10-APR-14MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)PENTAX MEDICAL COMPANY 510(k) NO: K13102894(TRADITIONAL)ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880 3 Paragon Drive SE DECISION MADE: 10-APR-14MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETROMTA-ORTHOMTA IIBIOMTA 510(k) NO: K13282595(TRADITIONAL)ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-APR-14FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDERSTRYKER SUSTAINABILITY SOLUTIONS 510(k) NO: K13357896(TRADITIONAL)ATTN: JILL CLARK PHONE NO : 480 763 5300 1810 WEST DRAKE DRIVE SE DECISION MADE: 10-APR-14TEMPE AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORMCOVIDIEN 510(k) NO: K14033997(TRADITIONAL)ATTN: BRIANNA REYNOLDS PHONE NO : 303 305 2728 6135 GUNBARREL AVE. SE DECISION MADE: 10-APR-14BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST AIA-PACK C-PEPTIDE II CALIBRATOR SETTOSOH BIOSCIENCE, INC. 510(k) NO: K14064898(ABBREVIATED)ATTN: ROBERT L WICK PHONE NO : 650 636 8117
















6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 10-APR-14SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMELEMAITRE VASCULAR, INC. 510(k) NO: K14004299(TRADITIONAL)ATTN: BRYAN COWELL PHONE NO : 781 425 1727 63 SECOND AVENUE SE DECISION MADE: 10-APR-14BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTEX AND OTHERS PROPRIETARY NAMESONTEX BVBA 510(k) NO: K132208100(TRADITIONAL)ATTN: RACHEL PAUL PHONE NO : 317 034585 70PRINSESSEGRACHT 20 SE DECISION MADE: 10-APR-14THE HAGUE NL 2514AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL EXAMINATION GLOVESSHU TONG XINGHUA CO., LTD. 510(k) NO: K122176101(TRADITIONAL)ATTN: SU SONG SHI PHONE NO : 008 652 383495619WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14XINGHUA CH 225700 510(k) STATEMENT DEVICE: POWDER FREE VINYL EXAMINATION GLOVESSHU TONG XINGHUA CO., LTD. 510(k) NO: K122377102(TRADITIONAL)ATTN: SU SONG SHI PHONE NO : 008 652383 495619WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14XINGHUA CH 225700 510(k) STATEMENT DEVICE: RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEMRENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K132312103(TRADITIONAL)ATTN: SHARYN ORTON, PH.D. PHONE NO : 401 330 8264 200 HOMER AVE SE DECISION MADE: 11-APR-14ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPOSED OPTIMUSCUSTOM SPINE, INC. 510(k) NO: K132596104(TRADITIONAL)ATTN: HANAA SHAHIN PHONE NO : 973 808 0019 9 Campus Dr SE DECISION MADE: 11-APR-14PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVESATELEC-ACTEON GROUP 510(k) NO: K131906105(ABBREVIATED)ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 11-APR-14MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALL-BOND UNIVERSAL SC (NOT FINALIZED)BISCO, INC. 510(k) NO: K131734106(TRADITIONAL)ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 11-APR-14SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)INOVISE MEDICAL, INC. 510(k) NO: K131883107(TRADITIONAL)ATTN: EARL ANDERSON PHONE NO : 503 431 3800 8770 SW NIMBUS AVENUE SUITE D SE DECISION MADE: 11-APR-14BEAVERTON OR 97008 7196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR-FLOW HANDY 3.0E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132478108(TRADITIONAL)ATTN: CYNTHIA J NOLTE PHONE NO : 919 859 4207 62 FOREST ST., STE 300 SE DECISION MADE: 11-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBERHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K132138109(TRADITIONAL)ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222 1140 FIRST STREET SOUTH SE DECISION MADE: 11-APR-14COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVEEL ENDOSCOPIC RETRACTORRETRACTION LIMITED 510(k) NO: K133345110(TRADITIONAL)ATTN: STUART MORAN PHONE NO : 852 311 06011UNIT F, 2/F, HONG KONG INDUSTRIAL SE DECISION MADE: 11-APR-14SAI WAN, HONG KONG CH 999077 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: INION FREEDOMPININION OY 510(k) NO: K133932111(TRADITIONAL)ATTN: KATI MARTTINEN PHONE NO : 358 108306 600LAAKARINKATU 2 SE DECISION MADE: 11-APR-14TAMPERE FI 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSINTEGRA LIFESCIENCES CORPORATION 510(k) NO: K134047112(TRADITIONAL)ATTN: RUTHANNE VENDY PHONE NO : 717 840 3527 589 DAVIES DRIVE SE DECISION MADE: 11-APR-14YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEWORKS ANTERIOR LUMBAR DEVICESPINEWORKS, LLC 510(k) NO: K133340113(TRADITIONAL)ATTN: ROBERT POGGIE, PHD PHONE NO : 973 738 6097 815 IRIS LANE SE DECISION MADE: 11-APR-14VERO BEACH FL 32963 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DECLIPSESPECT LAPAROSCOPYSURGICEYE GMBH 510(k) NO: K133781114(TRADITIONAL)ATTN: MORITZ HOYER PHONE NO : 49 895499 89024FRIEDENSTRASSE 18A SE DECISION MADE: 11-APR-14MUNICH, BAVARIA GM 81671 510(k) STATEMENT DEVICE: REVOLUTION CTGE MEDICAL SYSTEMS, LLC 510(k) NO: K133705115(TRADITIONAL)ATTN: HELEN PENG PHONE NO : 262 424 8222 3000 N GRANDVIEW BLVD. SE DECISION MADE: 11-APR-14WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-PM-DISCMERZ DENTAL GMBH 510(k) NO: K134015116(TRADITIONAL)ATTN: RICHARD G HUNTER PHONE NO : 505 400 4992 5616 MARIOLA PL NE SE DECISION MADE: 11-APR-14ALBUQUERQUE NM 87111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLETREFLECTANCE MEDICAL INC 510(k) NO: K133923117(TRADITIONAL)ATTN: NANDINI MURTHY PHONE NO : 781 710 5378 116 FLAUNDERS ROAD, SUITE 1000 SE DECISION MADE: 11-APR-14WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIBRALT ROD-TO-ROD CROSS CONNECTORSEXACTECH SARASOTA 510(k) NO: K140645118(SPECIAL)ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 7455 16th Street East Suite 105 SE DECISION MADE: 11-APR-14Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717GRAYENCE CO., LTD 510(k) NO: K140646119(SPECIAL)ATTN: DAVE KIM PHONE NO : 713 467 2607 8310 BUFFALO SPEEDWAY SE DECISION MADE: 11-APR-14HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AZE PHOENIX SOFTWAREAZE, LTD. 510(k) NO: K133521120(TRADITIONAL)ATTN: KARL DIEDRICH, AZE PHONE NO : 617 475 15021-8-1 MARUNOUCHI, CHIYODA-KU SE DECISION MADE: 11-APR-14TOKYO JA 100-0005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ERCHONIA ALLAYERCHONIA MEDICAL, INC. 510(k) NO: K132940121(TRADITIONAL)ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 14-APR-14LITTLETON CO 80127 510(k) STATEMENT DEVICE: DISCOSCOPES, CERVICAL ENDOSCOPESRZ MEDIZINTECHNIK GMBH 510(k) NO: K130778122(TRADITIONAL)ATTN: ANDRE WEINGREL PHONE NO : 49 7463 99540GRIESWEG 47 SE DECISION MADE: 14-APR-14MUEHLHEIM, BADEN-WUERTTEMBERG G510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANCE® FOAM ABDOMINAL DRESSING KITMOLNLYCKE HEALTHCARE 510(k) NO: K130852123(TRADITIONAL)
















ATTN: ANGELA L BUNN PHONE NO : 678 250 7930 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 14-APR-14NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL STAND ALONE SYSTEMORTHOFIX INC. 510(k) NO: K132999124(TRADITIONAL)ATTN: NATALIA VOLOSEN PHONE NO : 214 937 2145 3451 PLANO PARKWAY SE DECISION MADE: 14-APR-14LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYHEALTHPOINT TELEHEALTH MANAGERENTRA HEALTH SYSTEMS 510(k) NO: K132930125(TRADITIONAL)ATTN: RICHARD STROBRIDGE PHONE NO : 877 458 2646 3111 Camino Del Rio North Suite 10SE DECISION MADE: 14-APR-14San Diego CA 92108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICASSO II MIS SPINAL SYSTEMACCEL SPINE 510(k) NO: K140219126(SPECIAL)ATTN: LISA PETERSON PHONE NO : 512 507 0746 14001 HUNTERS PASS SE DECISION MADE: 14-APR-14AUSTIN TX 78734 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEGALEMED CORP. 510(k) NO: K133957127(TRADITIONAL)ATTN: PAUL DRYDEN PHONE NO : 239 498215 5AMOY EXPORT PROCESSING ZONE, 39 SESE DECISION MADE: 14-APR-14XIAMEN, FUJIAN CH 361000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CABOCHON SYSTEMCABOCHON AESTHETICS, INC. 510(k) NO: K134010128(TRADITIONAL)ATTN: BEN F BRIAN, PH.D. PHONE NO : 650 543 7110 127 INDEPENDENCE DRIVE SE DECISION MADE: 14-APR-14MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELISIO-H HEMODIALYZERNIPRO MEDICAL CORPORATION 510(k) NO: K140191129(SPECIAL)ATTN: CAROLYN GEORGE PHONE NO : 305 599 7174 3150 NW 107 AVE., SE DECISION MADE: 14-APR-14MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAMIC RCS SYRINGENAVILYST MEDICAL, INC. 510(k) NO: K140194130(ABBREVIATED)ATTN: BRANDON M BRACKETT PHONE NO : 508 658 7984 26 FOREST STREET SE DECISION MADE: 14-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COGENT MED-LIFCOGENT SPINE LLC 510(k) NO: K132738131(TRADITIONAL)ATTN: JUDE PAGANELLI PHONE NO : 858 774 7891 101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 15-APR-14SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXZERO EXTENSION SET WITH NEEDLESS CONNECTORCAREFUSION 510(k) NO: K140831132(TRADITIONAL)ATTN: LARRY WALKER PHONE NO : 10020 PACIFIC MESA BLVD SE DECISION MADE: 15-APR-14SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBERBOSTON SCIENTIFIC 510(k) NO: K140503133(TRADITIONAL)ATTN: JEANNE O'TOOLE PHONE NO : 508 683 4271 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 15-APR-14MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 6200 / 6250 ULTRASOUND SYSTEMESAOTE S.P.A. 510(k) NO: K133905134(TRADITIONAL)ATTN: ALLISON SCOTT PHONE NO : 317 228 8719 9001 WESLEYAN ROAD, SUITE 200 SE DECISION MADE: 15-APR-14INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEMEPS BIO TECHNOLOGY CORP. 510(k) NO: K133389135(SPECIAL)ATTN: CYNTHIA HUNG PHONE NO : 886 3 6686868















NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 15-APR-14HSINCHU CITY, TW 30077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPLPAN MEDICAL LTD 510(k) NO: K132620136(TRADITIONAL)ATTN: JENNIE BUDDING PHONE NO : 44 1452 621621BARNETT WAY, BARNWOOD SE DECISION MADE: 16-APR-14GLOUCESTER, GLOUCESTERSHIRE UK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]STERNGOLD DENTAL LLC 510(k) NO: K133791137(ABBREVIATED)ATTN: MARIA RAO PHONE NO : 508 556 5660 23 FRANK MOSSBERG DRIVE SE DECISION MADE: 16-APR-14ATTLEBORO MA 02703 0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)CURRIE MEDICAL SPECIALTIES, INC. 510(k) NO: K140092138(TRADITIONAL)ATTN: OWEN J BRY PHONE NO : 909 912 0900 8758 Hellman Ave SE DECISION MADE: 16-APR-14Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATIONAMERIWATER 510(k) NO: K133783139(TRADITIONAL)ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833 1303 STANLEY AVE. SE DECISION MADE: 16-APR-14DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTATING ADAPTERSMERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140475140(TRADITIONAL)ATTN: CORY MARSH PHONE NO : 801 316 3690 1600 WEST MERIT PKWY. SE DECISION MADE: 16-APR-14SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSERTION TOOLBOSTON SCIENTIFIC CORP. 510(k) NO: K140673141(SPECIAL)ATTN: LISA MEE PHONE NO : 763 494 1185 ONE SCIMED PLACE SE DECISION MADE: 16-APR-14MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTESS CERVICAL CAGE SYSTEMKALITEC DIRECT, LLC 510(k) NO: K133815142(TRADITIONAL)ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 16-APR-14ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUEPATH CTO DEVICEBOSTON SCIENTIFIC CORP. 510(k) NO: K140288143(SPECIAL)ATTN: CAROL TIFFANY PHONE NO : ONE SCIMED PLACE SE DECISION MADE: 16-APR-14MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTSORIGIO A/S 510(k) NO: K133707144(TRADITIONAL)ATTN: TOVE KJAER PHONE NO : 45 4679 0200Knardrupvej 2 SE DECISION MADE: 16-APR-14Maaloev DA 2760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMHITACHI ALOKA MEDICAL, LTD. 510(k) NO: K140639145(TRADITIONAL)ATTN: ANGELA VANARSDALE PHONE NO : 203 269 5088 10 FAIRFIELD BLVD. SE DECISION MADE: 16-APR-14WALLINGFORD CT CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVMED DDR 2430TPORTAVISION MEDICAL LLC 510(k) NO: K133524146(TRADITIONAL)ATTN: TERRY ANCAR PHONE NO : 866 783 4133 5401 COCOS PLUMOSAS DRIVE SE DECISION MADE: 16-APR-14KENNER LA 70065 510(k) STATEMENT DEVICE: ADVATXADVALIGHT APS 510(k) NO: K132976147(TRADITIONAL)ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 17-APR-14NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: NEOV DIODE LASER FAMILYG.N.S NEOLASER LTD. 510(k) NO: K133006148(TRADITIONAL)ATTN: GIL SHAPIRA PHONE NO : 972 467 799197 HA'ESHEL STR SE DECISION MADE: 17-APR-14CAESAREA IS 38900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART (SMART-D, SMART-DX)BTS SPA 510(k) NO: K131660149(TRADITIONAL)ATTN: ENRICO BISSON PHONE NO : 39 049981 5500VIA CROCE ROSSA, 11 SE DECISION MADE: 17-APR-14PADOVA IT 35129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HC-1 AND HC-1 CLASSICTRANSCENDENCIAS COMERCIALES SL TRA510(k) NO: K131852150(TRADITIONAL)ATTN: RAMON ECHEVARRIA PHONE NO : 34 943 224360C/ZUBIBERRI 31- PLANTA BAJA LOCAL SE DECISION MADE: 17-APR-14SAN SEBASTIAN, GUIPUZCOA SP 200510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)MONARCH MEDICAL TECHNOLOGIES 510(k) NO: K132547151(ABBREVIATED)ATTN: ANN A GRAHAM PHONE NO : 240 476 3477 3457 CHISWICK COURT SE DECISION MADE: 17-APR-14SILVER SPRING MD 20906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-STATIONPHILIPS ULTRASOUND, INC. 510(k) NO: K140808152(TRADITIONAL)ATTN: PENNY GRECO PHONE NO : 3000 MINUTEMAN RD. SE DECISION MADE: 17-APR-14ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)BECKMAN COULTER, INC. 510(k) NO: K131189153(TRADITIONAL)ATTN: YVETTE LLOYD PHONE NO : 714 307 3469 250 S. KRAEMER ST SE DECISION MADE: 17-APR-14BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODEBOSTON SCIENTIFIC CORP. 510(k) NO: K140495154(TRADITIONAL)ATTN: MATT BEAUCHANE PHONE NO : 763 494 1789 ONE SCIMED PLACE SE DECISION MADE: 17-APR-14MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESTINO TWIST, STEERABLE GUIDING SHEATHOSCOR INC. 510(k) NO: K140406155(SPECIAL)ATTN: TINA STRICKLAND PHONE NO : 727 937 2511 3816 DE SOTO BLVD. SE DECISION MADE: 17-APR-14PALM HARBOR FL 34683 510(k) STATEMENT DEVICE: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWSTRAUMANN USA, LLC 510(k) NO: K133421156(TRADITIONAL)ATTN: CHARLOTTE RINGLEB PHONE NO : 978 747 2552 60 MINUTEMAN ROAD SE DECISION MADE: 17-APR-14ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIS MODULIFT VBR SYSTEMAESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K133802157(TRADITIONAL)ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 17-APR-14CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALOCK PLATING SYSTEM / TUFFNEK SCREWPARAGON 28 510(k) NO: K140397158(TRADITIONAL)ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 P O BOX 566 SE DECISION MADE: 17-APR-14CHESTERLAND OH 44026 0566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIP INTRODUCER ACCESS KITVASCULAR SOLUTIONS, INC. 510(k) NO: K132789159(TRADITIONAL)ATTN: ELLIE GILLESPIE PHONE NO : 763 656 4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 17-APR-14MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX 2 SYSTEMSTRYKER TRAUMA AG 510(k) NO: K140769160(SPECIAL)
















ATTN: ELIJAH N WREH PHONE NO : 201 831 5691 325 CORPORATE ARIVE SE DECISION MADE: 17-APR-14MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEMBIONIME COPORATION 510(k) NO: K133522161(TRADITIONAL)ATTN: FENG-YU LEE PHONE NO : 949 951 3046 2700 LA PAZ ROAD SUITE 266B SE DECISION MADE: 17-APR-14MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM FORCESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133589162(TRADITIONAL)ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PKWY. SE DECISION MADE: 17-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INITARY BETTER BLADDER-PEDIATRICCIRCULATORY TECHNOLOGY, INC. 510(k) NO: K140321163(SPECIAL)ATTN: YEHUDA TAMARI PHONE NO : 516 624 2424 21 SINGWORTH ST. SE DECISION MADE: 17-APR-14OYSTER BAY NY 11771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEMAURORA SPINE, INC. 510(k) NO: K140715164(SPECIAL)ATTN: JUSTI N EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 17-APR-14WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUFACE MINI DEVICECAROL COLE COMPANY 510(k) NO: K133823165(ABBREVIATED)ATTN: RAND DAOUD PHONE NO : 760 734 4545 1325 Sycamore Ave Ste A SE DECISION MADE: 17-APR-14Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERGONOMIC PRODUCTS WORKSTATIONERGONOMIC PRODUCTS, INC. 510(k) NO: K132315166(TRADITIONAL)ATTN: RENEE GOULD PHONE NO : 401 651 6513 240 ANNETTE AVE SE DECISION MADE: 18-APR-14WOONSOCKET RI 02895 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGESGS MEDICAL CO., LTD. 510(k) NO: K131612167(TRADITIONAL)ATTN: DONALD W GUTHNER PHONE NO : 646 460 2984 111 HILL ROAD SE DECISION MADE: 18-APR-14DOUGLASSVILLE PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)MINDRAY NORTH AMERICA 510(k) NO: K132075168(ABBREVIATED)ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391 800 MACARTHUR BLVD SE DECISION MADE: 18-APR-14MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPASS CT, COMPASS CT PORTMIRADOR BIOMEDICAL 510(k) NO: K133624169(TRADITIONAL)ATTN: JUSTIN HULVERSHORN PHONE NO : 206 295 3372 2815 EASTLAKE AVE E SUITE 220 SE DECISION MADE: 18-APR-14SEATTLE WA 98102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT PUTTY, MASTERGRAFT STRIPMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140375170(TRADITIONAL)ATTN: KELLY ANGLIN PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 18-APR-14Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK ARTHROSCOPESMEDOS INTERNATIONAL SARL 510(k) NO: K133941171(TRADITIONAL)ATTN: SUSAN KAGAN PHONE NO : 508 880 8097CHEMIN-BLANC 38, CASE POSTALE SE DECISION MADE: 18-APR-14LE LOCLE SZ CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTLECARE AR APPLICATORGC MEDTECH, LLC 510(k) NO: K133922172(TRADITIONAL)ATTN: GREGORY MATHISON PHONE NO : 218 387 1559 3924 CASCADE BEACH ROAD SE DECISION MADE: 18-APR-14LUTSEN MN 55612 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTINGANGIOSCORE, INC. 510(k) NO: K133998173(TRADITIONAL)ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989 5055 BRANDIN COURT SE DECISION MADE: 18-APR-14FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALAXY CO2 LASER SYSTEMBEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K133915174(TRADITIONAL)ATTN: ZHANG XIAOSONG PHONE NO : 86 106435 4759EAST 3RD FL, BLDG M7 # 1 JIUXIANQISE DECISION MADE: 18-APR-14CHAOYANG DISTRICT, BEIJING CH 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSORB LSBIOMET, INC. 510(k) NO: K140625175(TRADITIONAL)ATTN: VICTORIA SCHEITLIN PHONE NO : 574 372 6801 56 EAST BELL DR. SE DECISION MADE: 18-APR-14WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JULIET OLSPINEART 510(k) NO: K140474176(TRADITIONAL)ATTN: FRANK PENNESI PHONE NO : 41 22 7994025INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 18-APR-14GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAYCOOK, INC. 510(k) NO: K133597177(TRADITIONAL)ATTN: SEAN SPENCE PHONE NO : 812 335 3575 750 DANIELS WAY SE DECISION MADE: 18-APR-14BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P-PODP-POD 510(k) NO: K133397178(TRADITIONAL)ATTN: LINDA BRADDON PHONE NO : 770 837 2681 7828 HICKORY FLAT HWY. SUITE 120 SE DECISION MADE: 18-APR-14WOODSTOCK GA 30188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCKESSON CARDIOLOGY ECG MOBILEMCKESSON ISRAEL LTD. 510(k) NO: K133534179(TRADITIONAL)ATTN: PAUL SUMNER PHONE NO : 404 338 3556 5995 WINDWARD PARKWAY SE DECISION MADE: 18-APR-14ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVOY GUIDING CATHETERCODMAN & SHURTLEFF, INC. 510(k) NO: K140307180(SPECIAL)ATTN: HANNAH FOLEY PHONE NO : 305 265 6810 325 PARAMOUNT DR. SE DECISION MADE: 21-APR-14RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALAMO TALLIANCE PARTNERS, LLC. 510(k) NO: K140303181(SPECIAL)ATTN: KELLEN HILLS PHONE NO : 901 433 1990 4600 E SHELBY DR SE DECISION MADE: 21-APR-14MEMPHIS TN 38118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULACAREFUSION 2200 INC. 510(k) NO: K140761182(SPECIAL)ATTN: JANE WEBER PHONE NO : 847 362 8094 72 N. FAIRWAY DRIVE SE DECISION MADE: 21-APR-14VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTINCT; PLAIN, DOTTED, ULTRA THINPROFILATEX, S.A. DE C.V. 510(k) NO: K132390183(ABBREVIATED)ATTN: JUAN ERNESTO DE LA PUENTE PHONE NO : 52 555975 6060FEBRERO DE 1917 #4 COL. CIPRESES SE DECISION MADE: 22-APR-14CHALCO MX 56600 510(k) STATEMENT DEVICE: HEPATIC VCARGE MEDICAL SYSTEMS SCS 510(k) NO: K133649184(TRADITIONAL)ATTN: HUY DOAN PHONE NO : 262 312 7751 3000 N. GRANDVIEW SE DECISION MADE: 22-APR-14WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133761185(TRADITIONAL)
















ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DRIVE SE DECISION MADE: 22-APR-14TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSOURCE SELECTABLE IV SETMEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K140442186(SPECIAL)ATTN: JENNIFER NESS PHONE NO : 952 241 8318 5346 SHORELINE DR. SE DECISION MADE: 22-APR-14MOUND MN 55364 510(k) STATEMENT DEVICE: ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATINGETHICON ENDO-SURGERY, LLC 510(k) NO: K140560187(TRADITIONAL)ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK ROAD SE DECISION MADE: 22-APR-14CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGEBIO-MEDICAL CARBON TECHNOLOGY CO.,510(k) NO: K140147188(TRADITIONAL)ATTN: DIANE SUDDUTH PHONE NO : 512 327 9997 816 CONGRESS AVE. STE 1400 SE DECISION MADE: 22-APR-14AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFVIVONIC GMBH 510(k) NO: K133829189(TRADITIONAL)ATTN: ANDREAS HESSBERGER PHONE NO : 49 6093 971311KURFUERST-EPPSTEIN-RING 4 SE DECISION MADE: 22-APR-14SAILAUF GM 63877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTIP COVERACCUTOME, INC. 510(k) NO: K132549190(TRADITIONAL)ATTN: ADAM PICKHOLTZ PHONE NO : 610 889 0200 3222 PHOENIXVILLE PIKE SE DECISION MADE: 23-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSONTEX BVBA 510(k) NO: K132595191(TRADITIONAL)ATTN: RACHEL PAUL PHONE NO : 31 70 3458570PRINSESSEGRACHT 20 SE DECISION MADE: 23-APR-14THE HAGUE NL 2514AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUM 100PROPROMEDIC, INC. 510(k) NO: K131889192(TRADITIONAL)ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR SE DECISION MADE: 23-APR-14BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASAL MASK, NASAL MASK, FULL FACE MASKBMC MEDICAL CO., LTD 510(k) NO: K133009193(TRADITIONAL)ATTN: MS. JINJING PHONE NO : 5/F Main Building No.19 Gucheng StSE DECISION MADE: 23-APR-14Beijing CN 100043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTERVUE MACULAR INTEGRITY ASSESSMENTCENTERVUE SPA 510(k) NO: K133758194(TRADITIONAL)ATTN: ROGER GRAY PHONE NO : 39 06 5782665PIAZZA ALBANIA 10 SE DECISION MADE: 23-APR-14ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XQ-1 INCUBATORAT MEDICAL UAB 510(k) NO: K133742195(TRADITIONAL)ATTN: THOMAS PEDERSEN PHONE NO : 004 526340 702DRAUGYSTES G.19 SE DECISION MADE: 23-APR-14KAUNAS LH 51230 510(k) STATEMENT DEVICE: DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MACIMAGING SCIENCES INTERNATIONAL, LL510(k) NO: K140445196(SPECIAL)ATTN: SANJAY AHUJA PHONE NO : 267 954 1463 1910 NORTH PENN RD. SE DECISION MADE: 23-APR-14HATFIELD PA 19440 510(k) STATEMENT DEVICE: AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)XLUMENA, INC. 510(k) NO: K140561197(SPECIAL)ATTN: JANE BEGGS PHONE NO : 650 961 9900 453 RAVENDALE DRIVE. SUITE H SE DECISION MADE: 23-APR-14MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: FORTRESS PEDICLE SCREW SYSTEMSPINEOLOGY, INC. 510(k) NO: K140010198(TRADITIONAL)ATTN: KAREN ROCHE PHONE NO : 651 256 8513 7800 3RD ST NORTH SUITE 600 SE DECISION MADE: 23-APR-14ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETERINFRAREDX, INC. 510(k) NO: K133897199(TRADITIONAL)ATTN: STEVEN J CHARTIER PHONE NO : 781 345 9593 34 THIRD AVE SE DECISION MADE: 23-APR-14BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY IGS 740GE MEDICAL SYSTEMS SCS 510(k) NO: K133278200(TRADITIONAL)ATTN: MICHEL GENUER PHONE NO : 33 13070 4741283 RUE DE LA MINIERE SE DECISION MADE: 24-APR-14BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDEFIBTECH, LLC 510(k) NO: K131525201(TRADITIONAL)ATTN: ED HORTON PHONE NO : 203 453 6654 741 BOSTON POST ROAD,SUITE 201 SE DECISION MADE: 24-APR-14GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURAGEN 3DINTEGRA LIFESCIENCES CORPORATION 510(k) NO: K130557202(TRADITIONAL)ATTN: STEPHEN H BEIER PHONE NO : 609 936 5436 311 ENTERPRISE DR. SE DECISION MADE: 24-APR-14PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINOOK MASSAGERPINOOK USA 510(k) NO: K132563203(TRADITIONAL)ATTN: TEJAS SHAH PHONE NO : 858 657 9226 5703 OBERLIN DRIVE STE 306 SE DECISION MADE: 24-APR-14SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131838204(TRADITIONAL)ATTN: MIKE GU PHONE NO : 86 206232 13337TH FL. JINGGUI BUSINESS BLDG NO. SE DECISION MADE: 24-APR-14GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRIC BREAST PUMPSHANTOU XINGHE ELECTRICAL APPARATU510(k) NO: K132882205(TRADITIONAL)ATTN: MIKE GU PHONE NO : 86 206232 13337TH FLOOR, JINGUI BUSINESS BLDG, NSE DECISION MADE: 24-APR-14GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX3000-LDEXCOWIN CO., LTD 510(k) NO: K133007206(SPECIAL)ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 0450 110 EAST GRANADA BLVD. SUITE 207 SE DECISION MADE: 24-APR-14ORMOND BEACH FL 32176 510(k) STATEMENT DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEACCLARENT, INC. 510(k) NO: K132433207(TRADITIONAL)ATTN: JAMES PATRICK GARVEY II PHONE NO : 650 687 4807 1525-B OBRIEN DR. SE DECISION MADE: 24-APR-14MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICK RELAX PROHEALTHCARE INNOVATIONS, LLC 510(k) NO: K131956208(TRADITIONAL)ATTN: SHEPARD G BENTLEY, RAC PHONE NO : 949 374 9187 28241 CROWN VALLEY PKWY, STE 510(KSE DECISION MADE: 24-APR-14LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XBCODMAN & SHURTLEFF, INC. 510(k) NO: K140080209(SPECIAL)ATTN: HANNAH FOLEY PHONE NO : 305 265 6810 325 PARAMOUNT DR. SE DECISION MADE: 24-APR-14RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS SPINAL SYSTEM -TRANSLATION SCREWEBI, LLC 510(k) NO: K140123210(TRADITIONAL)
















ATTN: MIKE MEDINA PHONE NO : 303 501 8548 399 Jefferson Rd SE DECISION MADE: 24-APR-14PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUID LEVEL MONITORCOLEMAN LABORATORIES 510(k) NO: K133870211(TRADITIONAL)ATTN: LE-JUN YIN PHONE NO : 484 727 8812 1150 FIRST AVENUE, SUITE 501 SE DECISION MADE: 24-APR-14KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOFILAMENT POLYPECTOMY SNAREUNITED STATES ENDOSCOPY 510(k) NO: K140763212(SPECIAL)ATTN: SAGAR D PIMPALWAR PHONE NO : 440 358 6265 5976 HEISLEY ROAD SE DECISION MADE: 24-APR-14MENTOR OH 44060 510(k) STATEMENT DEVICE: LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE COBIO-RAD LABORATORIES 510(k) NO: K134013213(TRADITIONAL)ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 24-APR-14IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COUNTER OTC TENS DEVICECOUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K132993214(TRADITIONAL)ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001 11820 RED HIBISCUS DRIVE SE DECISION MADE: 24-APR-14BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSPENTAX MEDICAL COMPANY 510(k) NO: K131946215(TRADITIONAL)ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880 3 Paragon Drive SE DECISION MADE: 25-APR-14MONTVALE NJ 07645 1782 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTANE ELEVATE SPINAL IMPLANT SYSTEMEXACTECH, INC. 510(k) NO: K123607216(TRADITIONAL)ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 N.W. 66TH CT. SE DECISION MADE: 25-APR-14GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEL-BEAD EMBOLIZATION SPHERESVASCULAR SOLUTIONS, INC. 510(k) NO: K133237217(TRADITIONAL)ATTN: ELLIE GILLESPIE PHONE NO : 763 656 4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 25-APR-14MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE MOSES ELITE APPLIANCEALLEN J. MOSES, DDS, LTD. 510(k) NO: K132933218(SPECIAL)ATTN: ALLEN J MOSES, DDS PHONE NO : 312 993 0430 233 S. WACKER DR. SE DECISION MADE: 25-APR-14CHICAGO IL 60606 510(k) STATEMENT DEVICE: MTA FILLAPEXANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K140247219(SPECIAL)ATTN: TARA CONRAD PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 25-APR-14AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEMZIMMER DENTAL INC. 510(k) NO: K134045220(TRADITIONAL)ATTN: JULIE LAMOTHE PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 25-APR-14CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTTOUCHNEXUS6, LTD. 510(k) NO: K133951221(TRADITIONAL)ATTN: GARTH SUTHERLAND PHONE NO : 64 930727 718 COMMERCE STREET SUITE 205 SE DECISION MADE: 25-APR-14AUCKLAND NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140851222(SPECIAL)ATTN: CDR YON YU, PHARM.D. PHONE NO : 404 639 3046 1600 CLIFTON ROAD, MAILSTOP D-30 SE DECISION MADE: 25-APR-14ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA















DEVICE: INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140857223(SPECIAL)ATTN: CDR YON YU, PHARM.D. PHONE NO : 404 639 3046 1600 CLIFTON ROAD, MS-C18 SE DECISION MADE: 25-APR-14ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY GO VACPRECISION MEDICAL, INC. 510(k) NO: K140179224(SPECIAL)ATTN: JAMES PARKER PHONE NO : 610 262 6090 300 HELD DR. SE DECISION MADE: 25-APR-14NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLABSSOGNOESAOTE S.P.A. 510(k) NO: K140677225(TRADITIONAL)ATTN: ALLISON SCOTT PHONE NO : 317 228 8719 9001 WESLEYAN ROAD, SUITE 200 SE DECISION MADE: 25-APR-14INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINIT SMALL BONE FUSION SYSTEMARTHROSURFACE, INC. 510(k) NO: K140617226(SPECIAL)ATTN: DAWN J WILSON PHONE NO : 508 520 3003 28 FORGE PARKWAY SE DECISION MADE: 25-APR-14FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAKBIO-RAD LABORATORIES 510(k) NO: K140764227(TRADITIONAL)ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 25-APR-14IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS ELEVA WORKSPOTPHILIPS MEDICAL SYSTEMS DMC GMBH 510(k) NO: K140771228(SPECIAL)ATTN: GEROLD SCHWARZ PHONE NO : 49 405078 1116ROENTGENSTRASSE 24-26 SE DECISION MADE: 25-APR-14HAMBURG GM 22335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE ANTERIOR CERVICAL PLATERELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K140742229(SPECIAL)ATTN: BRET M BERRY PHONE NO : 801 295 3280 P.O. BOX 1693 SE DECISION MADE: 25-APR-14BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K140749230(SPECIAL)ATTN: JEANINE REDDEN PHONE NO : 901 867 4522 1023 CHERRY ROAD SE DECISION MADE: 25-APR-14MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2300 SERIES MGO PORTABLE OXYGENULTRA ELECTRONICS LIMITED PRECISIO510(k) NO: K134023231(TRADITIONAL)ATTN: ANDY CHILTON PHONE NO : 441 242713 585ARLE COURT HATHERLEY LANE SE DECISION MADE: 25-APR-14CHELTENHAM, GLOUCESTERSHIRE UK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA CARE BLOOD PRESSURE MONITORING SYSTEMFORA CARE INC. 510(k) NO: K133588232(TRADITIONAL)ATTN: SHARON PENG PHONE NO : 886 266258 1886F, NO.127, WUGONG 2ND RD WUGU DISSE DECISION MADE: 25-APR-14NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERASON USMART3400 ULTRASOUND SYSTEMTERATECH CORP. 510(k) NO: K140834233(TRADITIONAL)ATTN: BEN CHIAMPA PHONE NO : 781 270 4143 77-79 TERRACE HALL AVE. SE DECISION MADE: 25-APR-14BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACESSA GUIDANCE HANDPIECEHALT MEDICAL INC 510(k) NO: K132184234(TRADITIONAL)ATTN: CLARISA TATE PHONE NO : 925 271 0626 131 SAND CREEK RD STE., B SE DECISION MADE: 28-APR-14BRENTWOOD CA 94513 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARASYS















ION GENIUS INC 510(k) NO: K132179235(TRADITIONAL)ATTN: XANYA SOFRA-WEISS, PH.D PHONE NO : 808 395 0656 1833 KALAKAUA AVE. SE DECISION MADE: 28-APR-14HONOLULU HI 96801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTEO, VIDEOGRAPH HDOWANDY 510(k) NO: K133271236(SPECIAL)ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 0450 110 EAST GRANADA BLVD, SUITE 207 SE DECISION MADE: 28-APR-14ORMOND BEACH FL 32176 32176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPANDX6D, LTD. 510(k) NO: K132042237(TRADITIONAL)ATTN: KAREL VAN GORP PHONE NO : 386 1520 562221 HANAFA STREET SE DECISION MADE: 28-APR-14ZUR- MOSHE IS 42810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETERBOSTON SCIENTIFIC CORPORATION 510(k) NO: K140733238(TRADITIONAL)ATTN: MICHELLE ROEDING PHONE NO : 408 935 3400 150 BAYTECH DRIVE SE DECISION MADE: 28-APR-14SAN JOSE CA 95124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAIMAN SEAL AND CUT TECHNOLOGYAESCULAP, INC. 510(k) NO: K140839239(SPECIAL)ATTN: DENISE ADAMS PHONE NO : 610 984 9076 3773 CORPORATE PARKWAY SE DECISION MADE: 28-APR-14CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMIC PEEK PTC CERVICAL FUSION SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133653240(TRADITIONAL)ATTN: JULIE BASSETT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 28-APR-14MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSP NEONATAL TOTAL GALACTOSE KITWALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K133652241(TRADITIONAL)ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781 663 6025 940 WINTER STREET SE DECISION MADE: 28-APR-14WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIS ONESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133580242(TRADITIONAL)ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 28-APR-14MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRELLA-SPEC(TM) VAGINAL SPECULUMPROA MEDICAL, INC. 510(k) NO: K133857243(TRADITIONAL)ATTN: VICTORIA NADERSHAHI PHONE NO : 310 717 5822 2512 Artesia Blvd Ste 305C SE DECISION MADE: 28-APR-14Redondo Beach CA 90278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURACYN PLUS SKIN AND WOUNDINNOVACYN, INC. 510(k) NO: K133542244(TRADITIONAL)ATTN: FRED L MA PHONE NO : 909 349 3370 3546 N. RIVERSIDE AVE. SE DECISION MADE: 28-APR-14RIALTO CA 92377 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPRINT ABLATION SYSTEMCOVIDIEN LLC 510(k) NO: K133821245(TRADITIONAL)ATTN: HEATHER V NIGRO PHONE NO : 508 452 1936 15 HAMPSHIRE ST SE DECISION MADE: 28-APR-14MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUCTION PUMPDING HWA CO., LTD 510(k) NO: K140031246(TRADITIONAL)ATTN: ROBERT O DEAN PHONE NO : 716 440 7362 1083 DELAWARE AVE. SE DECISION MADE: 28-APR-14BUFFALO NY 14223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENMATRIX SURGICAL GRAFTC.R. BARD 510(k) NO: K140501247(SPECIAL)ATTN: GINA CASSIDY PHONE NO : 401 825 8697 100 CROSSINGS BOULEVARD SE DECISION MADE: 28-APR-14
















WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURODYN COMPACT, NEURODYN IIIBRAMED EQUIPAMENTOS MEDICOS 510(k) NO: K131917248(TRADITIONAL)ATTN: TARA CONRAD PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 29-APR-14AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRIC HANDPIECE SYSTEMTTBIO CORP. 510(k) NO: K132570249(ABBREVIATED)ATTN: SHU-CHING LEE PHONE NO : 886 4 235959582F, NO.7, 6TH ROAD INDUSTRY PARK SE DECISION MADE: 29-APR-14TAICHUNG, ROC TW 40755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROMATE FRAMELESS GEN IIRENISHAW MAYFIELD SARL 510(k) NO: K132755250(TRADITIONAL)ATTN: STEPHANE VINOT PHONE NO : 011 33 43723890031, RUE AMPERE SE DECISION MADE: 29-APR-14CHASSIEU FR 69680 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEW STETIC DENTAL AMALGAM ALLOYNEW STETIC 510(k) NO: K140125251(TRADITIONAL)ATTN: JOHN O'BRIEN PHONE NO : 813 645 2855 445 APOLLO BEACH BLVD SE DECISION MADE: 29-APR-14APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF DISPOSABLE LENSESSENSOR MEDICAL TECHNOLOGY, LLC 510(k) NO: K140368252(TRADITIONAL)ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 29-APR-14NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK AVIVA PLUS SYSTEMROCHE DIAGNOSTICS CORPORATION 510(k) NO: K133862253(SPECIAL)ATTN: KHONE SAYSANA PHONE NO : 317 521 7593 9115 HAGUE ROAD SE DECISION MADE: 29-APR-14INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL SPINAL SYSTEMTIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K140229254(TRADITIONAL)ATTN: DIANA HONG PHONE NO : 86 21 22815850P.O. BOX 120-119 SE DECISION MADE: 29-APR-14SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTSOFT SOFT DENTURE LINER SYSTEMWHIP MIX CORP. 510(k) NO: K140146255(TRADITIONAL)ATTN: JOHN WATERS PHONE NO : 502 634 5357 361 FARMINGTON AVE SE DECISION MADE: 29-APR-14LOUISVILLE KY 40217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL REDORIGIO A/S 510(k) NO: K133387256(TRADITIONAL)ATTN: TOVE KJAER PHONE NO : 45 4679 0220KNARDRUPVEJ 2 SE DECISION MADE: 29-APR-14MALOV DA 2760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERCAS MEDICAL SYSTEMS, INC. 510(k) NO: K133879257(TRADITIONAL)ATTN: RON JEFFREY PHONE NO : 203 488 6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 29-APR-14BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAUTIFUL IMAGE FACIAL SCULPTING DEVICEBIOSONIC TECHNOLOGIES, LLC 510(k) NO: K130065258(TRADITIONAL)ATTN: SHEPARD G BENTLEY PHONE NO : 949 374 9187 28241 CROWN VALLEY PARKWAY SUITE 5SE DECISION MADE: 30-APR-14LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSTDI DENTAL IMPLANT SYSTEMMOSTDI INNOVATIONS SDN BHD 510(k) NO: K132178259(TRADITIONAL)ATTN: SUSAN PARK PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 30-APR-14BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC INPUT PS INTRODUCER















MEDTRONIC, INC. 510(k) NO: K132617260(TRADITIONAL)ATTN: NISARG SHAH PHONE NO : 978 739 6632 37A CHERRY HILL DRIVE SE DECISION MADE: 30-APR-14DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEMMAR COR PURIFICATION, INC. 510(k) NO: K133149261(TRADITIONAL)ATTN: KINNARI SHAH PHONE NO : 763 553 3369 14605 28TH AVENUE NORTH SE DECISION MADE: 30-APR-14MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMSSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140959262(TRADITIONAL)ATTN: CHRISTINE DUNN PHONE NO : 425 785 1617 685 EAST MIDDLEFIELD ROAD SE DECISION MADE: 30-APR-14MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FIAGON NAVIGATION SYSTEMFIAGON GMBH 510(k) NO: K133573263(TRADITIONAL)ATTN: DIRK MUCHA PHONE NO : 49 330220 12124NEUENDORFSTRASSE 23B SE DECISION MADE: 30-APR-14HENNIGSDORF GM 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM PERSPECTIVESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133590264(TRADITIONAL)ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PARKWAY SE DECISION MADE: 30-APR-14MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTORCOEUR, INC. 510(k) NO: K133600265(TRADITIONAL)ATTN: DEBRA F MANNING PHONE NO : 615 547 7923 100 PHYSICIANS WAY SUITE 200 SE DECISION MADE: 30-APR-14LEBANON TN 37090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTERFLEXICARE 510(k) NO: K133516266(TRADITIONAL)ATTN: CHRISTOPHER WATKINS PHONE NO : 441 443474 560CYNON VALLEY BUSINESS PARK MOUNTAISE DECISION MADE: 30-APR-14MID GLAM UK CF454ER 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K133882267(TRADITIONAL)ATTN: ROBERT CASARSA PHONE NO : 414 362 3063 8200 WEST TOWER AVE. SE DECISION MADE: 30-APR-14Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE 26 ADVANTAGE KITBOSTON SCIENTIFIC CORP. 510(k) NO: K140745268(SPECIAL)ATTN: LISA MEE PHONE NO : ONE SCIMED PLACE SE DECISION MADE: 17-APR-14MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPLIT CATH RGMEDCOMP 510(k) NO: K130889269(TRADITIONAL)ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 28-APR-14HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIESINTUITIVE SURGICAL, INC. 510(k) NO: K131962270(TRADITIONAL)ATTN: MIKE YRAMATEGUI PHONE NO : 408 523 2100 1266 KIFER ROAD SE DECISION MADE: 17-APR-14SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 270 TOTAL WITH SUMMARIES 251 TOTAL WITH STATEMENTS 19

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Medical Devices - FDA Regulatory Consulting...

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