Medical Devices
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July 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2012 DEVICE: K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER CURATIVE MEDICAL INC. 510(k) NO: K120285(TRADITIONAL) ATTN: AMY MCKINNEY PHONE NO : 979 236 1622 63 CHICORY CT SE DECISION MADE: 02-JUL-12 LAKE JACKSON TX 77566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN 510(k) NO: K113435(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 Henderson Drive SE DECISION MADE: 02-JUL-12 Caldwell NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY ELEKTA INC. D/B/A NUCLETRON CORPOR510(k) NO: K121448(TRADITIONAL) ATTN: THOMAS VALENTINE PHONE NO : 770 670 2548 7 ST. PAUL ST, STE 1660 SE DECISION MADE: 02-JUL-12 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTHMAPOLIS SYSTEM RECIPROCAL LABS CORPORATION 510(k) NO: K121609(TRADITIONAL) ATTN: INGER L COUTURE PHONE NO : 608 251 0470 612 W. MAIN STREET STE. 201 SE DECISION MADE: 02-JUL-12 MADISON WI 53703 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRINON Q & Q3 IMPLANT SYSTEM TRINON TITANIUM GMBH 510(k) NO: K103577(TRADITIONAL) ATTN: MARKUS DENK PHONE NO : 497 462 924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 03-JUL-12 TUTTLINGEN GM 78576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP INOTEC AMD LTD. 510(k) NO: K112634(TRADITIONAL) ATTN: DIANE HORWITZ PHONE NO : 703 307 2921 2995 STEVEN MARTIN DR. SE DECISION MADE: 03-JUL-12 FAIRFAX VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL ELEMENTS CERCLAGE SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K120177(TRADITIONAL) ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 03-JUL-12 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORANGE COLORED CONDOMS ORANGE SCENT KAREX INDUSTRIES SDN BHD 510(k) NO: K113056(SPECIAL) ATTN: LAI PENG LIM PHONE NO : 607 687 8833 PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 03-JUL-12 PONTIAN, JOHOR MY 82000 510(k) STATEMENT DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113262(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 03-JUL-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K120634(SPECIAL) ATTN: PINJUNG CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 03-JUL-12 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINE FRONTIER INDUS ACP SYSTEM SPINEFRONTIER, INC. 510(k) NO: K121060(SPECIAL) ATTN: FREDY H VARELA PHONE NO : 978 232 3990 500 CUMMINGS CENTER SUITE 3500 SE DECISION MADE: 03-JUL-12 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM CONSTANT CARE, LLC 510(k) NO: K120941(TRADITIONAL) ATTN: SETH A MAILHOT PHONE NO : 202 469 4980 1300 I ST, NW, 11TH FLOOR EAST SE DECISION MADE: 03-JUL-12 WASHINGTON DC 20005 3314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) GLOBUS MEDICAL, INC. 510(k) NO: K121107(SPECIAL) ATTN: SARAH M FITZGERALD PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 03-JUL-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K121669(SPECIAL) ATTN: STEVEN J BERKE PHONE NO : 513 772 8810 12011 MOSTELLER RD. SE DECISION MADE: 03-JUL-12 CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K121871(TRADITIONAL) ATTN: ROBERT ANDREW MILLER PHONE NO : 335 E. SONTERRA BLVD. SUITE 200 SE DECISION MADE: 03-JUL-12 SAN ANTONIO TX 78258 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR WILLIAM COOK EUROPE APS 510(k) NO: K121629(TRADITIONAL) ATTN: JENNIFER BROWN PHONE NO : 765 463 7537 1 GEDDES WAY SE DECISION MADE: 03-JUL-12 WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 SURGIQUEST, INC. 510(k) NO: K121336(SPECIAL) ATTN: DANIEL DONOVAN PHONE NO : 203 799 2400 333 Quarry Rd SE DECISION MADE: 03-JUL-12 Milford CT 06460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL BIOCHEMICAL DIAGNOSTIC, INC. 510(k) NO: K121122(TRADITIONAL) ATTN: ALLEN PANETZ PHONE NO : 631 595 9200 180 HEARTLAND BLVD. SE DECISION MADE: 03-JUL-12 Edgewood NY 11717 510(k) STATEMENT DEVICE: UTB BLUE POWDER FREE NITRILE NORTHSTAR HEALTHCARE HOLDINGS 510(k) NO: K121506(TRADITIONAL) ATTN: WESLEY TOAVS PHONE NO : 441 278 3827 HAMILTON HOUSE, 10 QUEEN ST SE DECISION MADE: 03-JUL-12 HAMILTON, BERMUDA EI HM11 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEPUY PULSE LUMBAR CAGE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K120966(TRADITIONAL) ATTN: ROBIN DINARDO PHONE NO : 508 977 3966 325 PARAMOUNT DRIVE SE DECISION MADE: 03-JUL-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERICAM PSI PERIMED AB 510(k) NO: K120884(TRADITIONAL) ATTN: MARIA LILJEVRET PHONE NO : 468 580 11990 DATAVAGEN 9 A SE DECISION MADE: 03-JUL-12 JARFALLA SE 17543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA ASTRA TECH INC. 510(k) NO: K120338(TRADITIONAL) ATTN: B A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERRACE SE DECISION MADE: 05-JUL-12 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILUMINAGE DIODE LASER CYNOSURE, INC. 510(k) NO: K111454(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978 256 4200 5 CARLISLE ROAD SE DECISION MADE: 05-JUL-12 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPURE PORTABLE RO SYSTEMS ARION WATER, INC. 510(k) NO: K112331(TRADITIONAL) ATTN: ROBERT LIVINGSTION PHONE NO : 508 465 2280 1 COMMERCE WAY BLDG 1 UNIT C SE DECISION MADE: 05-JUL-12 CARVER MA 02330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR NEXERA MEDICAL INC 510(k) NO: K120244(TRADITIONAL) ATTN: PAUL SALLARULO PHONE NO : 954 495 2020 3343 W Commercial Blvd Ste 103 SE DECISION MADE: 05-JUL-12 Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX MRSA ASSAY, BD MAX INSTRUMENT BD DIAGNOSTICS (GENEOHM SCIENCES C510(k) NO: K120138(TRADITIONAL) ATTN: RAYMOND J BOULE PHONE NO : 410 316 4542 7 LOVETON CIRCLE, MAIL CODE 614 SE DECISION MADE: 05-JUL-12 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF TL CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K121683(SPECIAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 05-JUL-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K121680(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 05-JUL-12 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K120636(TRADITIONAL) ATTN: JYH-SHYAN LIN PHONE NO : 301 251 1092 419 WEST AVE. SE DECISION MADE: 05-JUL-12 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K120739(TRADITIONAL) ATTN: BRAHIM HADRI PHONE NO : 781 249 8030 7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 05-JUL-12 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOPACS LUMEDX 510(k) NO: K120514(ABBREVIATED) ATTN: CHRIS PEARCE PHONE NO : 425 818 2312 110, 110TH AVE NE SE DECISION MADE: 05-JUL-12 BELLEVUE WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S DENTIN IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K120530(TRADITIONAL) ATTN: DANIELA LEVY PHONE NO : 213 447 5297 22817 VENTURA BLVD. #161 SE DECISION MADE: 05-JUL-12 WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLANT GO MATERIALISE DENTAL NV 510(k) NO: K120733(TRADITIONAL) ATTN: GEERT APPELTANS PHONE NO : 32 16 396620 TECHNOLOGIELAAN 15 SE DECISION MADE: 05-JUL-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE POWER FREE NITRILE EXAMINATION GLOVE CYPRESS MEDICAL PRODUCTS LLC 510(k) NO: K121464(TRADITIONAL) ATTN: ALEX NAGY PHONE NO : 815 385 0100 1202 SOUTH ROUTE 31 SE DECISION MADE: 05-JUL-12 MCHENRY IL 60050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR COOK INCORPORATED 510(k) NO: K120468(TRADITIONAL) ATTN: SUSANNE GALIN PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 06-JUL-12 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIS TORQUER NAVIS MEDICAL,INC 510(k) NO: K112674(TRADITIONAL) ATTN: MATTHEW J HUDDLESTON PHONE NO : 614 596 7204 5705 WHISPERING TRL SE DECISION MADE: 06-JUL-12 GALENA OH 43021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTDRIVE WHEELCHAIR POWER-ASSIST MAX MOBILITY, LLC 510(k) NO: K113621(TRADITIONAL) ATTN: WILLIAM M RICHTER PHONE NO : 615 731 1860 5425 MOUNT VIEW PARKWAY SE DECISION MADE: 06-JUL-12 ANTIOCH TN 37013 510(k) STATEMENT DEVICE: SAFETY SUBCUTANEOUS TISSUE INFUSION SET MULTI MED 510(k) NO: K120195(TRADITIONAL) ATTN: TANYA O'BRIEN PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 06-JUL-12 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MECHANICAL WHEELCHAIR NOVAF ANDALUCIA 2007, SL 510(k) NO: K120302(TRADITIONAL) ATTN: FERNANDO SAENZ DE SANTAMARIPHONE NO : 349 568 43675 CAMINO SE SANTA TERESA NAVE 1 SE DECISION MADE: 06-JUL-12 ROTA SP PC 11520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM APEX BIO TECHNOLOGY CORP 510(k) NO: K120649(SPECIAL) ATTN: LISA LIU PHONE NO : 011 886 35641952 NO. 7, LI-HSIN ROAD V HSINCHU SCIESE DECISION MADE: 06-JUL-12 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MULTILOC HUMERAL NAILING SYSTEM SYNTHES USA PRODUCTS LLC 510(k) NO: K120807(TRADITIONAL) ATTN: REBECCA BLANK PHONE NO : 610 719 1268 1301 GOSHEN PARKWAY SE DECISION MADE: 06-JUL-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNFLOWER WARNER ATOM MEDICAL CORPORATION 510(k) NO: K120937(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 06-JUL-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE SYNTHES USA 510(k) NO: K121601(TRADITIONAL) ATTN: ANGELA F LASSANDRO PHONE NO : 610 719 6854 1301 GOSHEN PKWY SE DECISION MADE: 06-JUL-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K120726(TRADITIONAL) ATTN: CHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 JN PEASE PLACE SE DECISION MADE: 06-JUL-12 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K121125(TRADITIONAL) ATTN: JOSEPH C GRIFFIN III PHONE NO : 732 578 0060 23 Christopher Way, Suite 103 SE DECISION MADE: 06-JUL-12 Eatontown NJ 07724 510(k) STATEMENT DEVICE: VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L & K BIOMED CO., LTD 510(k) NO: K121096(SPECIAL) ATTN: KI HYANG KIM PHONE NO : 822 262 41471 ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 06-JUL-12 SEOUL KS 153803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE SACKS HOLDINGS, INC. 510(k) NO: K121030(TRADITIONAL) ATTN: DEVIN CHODOROW PHONE NO : 617 510 8796 P.O. BOX 676211 SE DECISION MADE: 06-JUL-12 RANCHO SANTA FE CA 92067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEATLUX HOME SKINOVATIONS LTD. 510(k) NO: K120582(TRADITIONAL) ATTN: AMIR WALDMAN, PH.D PHONE NO : 972 547 404616 TAVOR BULD. POB 533 SE DECISION MADE: 06-JUL-12 YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV THINKING SYSTEMS CORP. 510(k) NO: K120305(TRADITIONAL) ATTN: JB WANG PHONE NO : 727 217 0909 750 94TH AVE., N. SUITE 211 SE DECISION MADE: 09-JUL-12 SAINT PETERSBURG FL 33702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANA-SCREEN WITH MDSS BIO-RAD LABORATORIES 510(k) NO: K113610(SPECIAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 09-JUL-12 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEVIIN REVERSE SHOULDER INGEN ORTHOPEDICS LLC 510(k) NO: K120374(TRADITIONAL) ATTN: PERRY GEREMAKIS PHONE NO : 609 409 3316 2650 US HIGHWAY 130 SE DECISION MADE: 09-JUL-12 CRANBURY NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYBAND WOUND DRESSING O2S, LLC 510(k) NO: K121407(TRADITIONAL) ATTN: DAVID E PETKO, P.E. PHONE NO : 215 299 8742 1500 SPRING GARDEN ST SE DECISION MADE: 09-JUL-12 PHILADELPHIA PA 19130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-SCAN ESAOTE, S.P.A. 510(k) NO: K121650(SPECIAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 09-JUL-12 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM COVIDIEN LLC 510(k) NO: K120773(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 10-JUL-12 ECHO OR 97826 . 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. 510(k) NO: K120263(TRADITIONAL) ATTN: JAE KIM PHONE NO : 714 289 8020 1073 N. BATAVIA ST SE DECISION MADE: 10-JUL-12 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY GYRUS ACMI, INC. 510(k) NO: K120474(TRADITIONAL) ATTN: GRAHAM BAILLE PHONE NO : 508 804 2738 136 TURNPIKE RD. SE DECISION MADE: 10-JUL-12 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATIM 2000 G4 CASSETTE SCICAN LTD. 510(k) NO: K112872(SPECIAL) ATTN: TERESA BOYCE PHONE NO : 416 445 1600 1440 DON MILLS RD. SE DECISION MADE: 10-JUL-12 TORONTO, ONTARIO CA M3B 3P9 510(k) STATEMENT DEVICE: CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM I-SENS, INC. 510(k) NO: K121133(SPECIAL) ATTN: HYUN JOON OH PHONE NO : 822 916 6191 465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 10-JUL-12 SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMAX PEDIATRIC SE TOTAL FACE MASK RESPIRONICS, INC. 510(k) NO: K120639(TRADITIONAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 10-JUL-12 PITTSBURGH PA 15239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS SYNERGETICS, INC 510(k) NO: K121426(TRADITIONAL) ATTN: GARY OLIVEROS PHONE NO : 636 794 5107 3845 CORPORATE CENTRE DRIVE SE DECISION MADE: 10-JUL-12 O'FALLON MO 63368 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECTPATH CYBERNET SYSTEMS CO., LTD. 510(k) NO: K121449(TRADITIONAL) ATTN: DIANE SUDDUTH PHONE NO : 512 327 9997 611 WEST 5TH ST. SE DECISION MADE: 10-JUL-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS LIGHTSCALPEL LLC 510(k) NO: K121471(TRADITIONAL) ATTN: GERALD S PALECKI PHONE NO : 425 408 9477 16932 WOOD-RED RD NE STE 201 SE DECISION MADE: 10-JUL-12 WOODINVILLE WA 98072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V5MS TRANSDUCER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121807(SPECIAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 2500 Millbrook Dr. Suite B SE DECISION MADE: 10-JUL-12 Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES WEALTH ON (JIANGSU) CO., LTD 510(k) NO: K120584(TRADITIONAL) ATTN: CHARLES SHEN PHONE NO : 001 608 2179358 5 CAREY ST SE DECISION MADE: 10-JUL-12 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM SPINAL USA LLC 510(k) NO: K112748(TRADITIONAL) ATTN: FRANKIE CUMMINS PHONE NO : 601 420 4244 2050 Executive Dr SE DECISION MADE: 11-JUL-12 Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSOURCE IV ADMINSTRATION SET MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K120424(TRADITIONAL) ATTN: JENNIFER NESS PHONE NO : 952 472 0131 5346 SHORELINE DRIVE SE DECISION MADE: 11-JUL-12 MOUND MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONGOOSE ANGIOGRAPHIC CATHETER PEDIACATH INC. 510(k) NO: K113819(TRADITIONAL) ATTN: CAROLINE TONTINI PHONE NO : 512 327 9997 611 WEST 5TH STREET SE DECISION MADE: 11-JUL-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO THE BINDING SITE GROUP LTD 510(k) NO: K113349(TRADITIONAL) ATTN: MARIANNE SENDER PHONE NO : 440 121 4569500 8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 11-JUL-12 BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT DEVICE: M/29TM - PRESSURE INJECTABLE FLEXICATH LTD. 510(k) NO: K111939(TRADITIONAL) ATTN: TALI HAZAN PHONE NO : 972 50 5292304 120 YIGAL ALON ST. CALIFORNIA BLDGSE DECISION MADE: 11-JUL-12 TEL AVIV IS 67443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYMFORM DUAL FLEX BELT MODEL WB-162 WELL BRAIN INTERNATIONAL, LTD. 510(k) NO: K111781(TRADITIONAL) ATTN: VICTOR K WAI PHONE NO : 852 261 90833 100 GRANVILLE ROAD TSIM SHA TSUI ESE DECISION MADE: 11-JUL-12 HONG KONG, SAR CHINA CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINICAT XORAN TECHNOLOGIES, INC. 510(k) NO: K113421(SPECIAL) ATTN: MARTHA RUMFORD PHONE NO : 734 418 5156 5210 South State Road SE DECISION MADE: 11-JUL-12 Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K121794(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 11-JUL-12 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POISE PERSONAL LUBRICANT KIMBERLY-CLARK CORPORATION 510(k) NO: K120650(TRADITIONAL) ATTN: SWARNA MUKUND PHONE NO : 770 587 8083 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 11-JUL-12 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) RANDOX LABORATORIES, LTD. 510(k) NO: K121746(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413 55 DIAMOND RD. SE DECISION MADE: 11-JUL-12 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION C.R. BARD, INC. 510(k) NO: K121856(SPECIAL) ATTN: ERIN FOX PHONE NO : 480 379 2841 1625 WEST 3RD ST. SE DECISION MADE: 11-JUL-12 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM LIEBEL-FLARSHEIM 510(k) NO: K121838(TRADITIONAL) ATTN: CRAIG BUEHLER PHONE NO : 314 654 3188 2111 EAST GALBRAITH RD SE DECISION MADE: 11-JUL-12 CINCINNATI OH 45237 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AC LENS BRANDED CONTACT LENS CASE ARLINGTON CONTACT LENS SERVICES,IN510(k) NO: K120969(TRADITIONAL) ATTN: CHRISTIAN SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 11-JUL-12 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS1000 LIGHT THERAPY DEVICE GENESIS HEALTH LIGHT CORPORATION 510(k) NO: K110558(TRADITIONAL) ATTN: PAUL ZIEMER PHONE NO : 289 895 8479 7 INNOVATION DRIVE SUITE 102 SE DECISION MADE: 12-JUL-12 HAMILTON, ONTARIO CA L9H 7H9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYRIAN 1.11 INTRASENSE 510(k) NO: K113620(TRADITIONAL) ATTN: FREDERIC BANEGAS PHONE NO : 334 671 30130 1231 AVENUE DU MONDIAL 98 SE DECISION MADE: 12-JUL-12 MONTPELLIER FR 34000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN 510(k) NO: K113436(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 Henderson Drive SE DECISION MADE: 12-JUL-12 Caldwell NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW REVERSE SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K112193(TRADITIONAL) ATTN: PATRICIA DONNARD PHONE NO : 332 985 56895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 12-JUL-12 QUIMPER FR 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACK NITRILE POWDER-FREE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS 510(k) NO: K121529(TRADITIONAL) ATTN: WESLEY TOAVS PHONE NO : 441 278 3827 HAMILTON HOUSE, 10 QUEEN ST SE DECISION MADE: 12-JUL-12 HAMILTON, BERMUDA EI HM11 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 0.9% SODIUM CHLORIDE FLISH SYRINGE AMUSA 510(k) NO: K120836(SPECIAL) ATTN: KAREN THOMISON PHONE NO : 615 833 2633 5209 Linbar Dr Ste 640 SE DECISION MADE: 12-JUL-12 NASHVILLE TN 37211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER BIOPSY SCIENCES, LLC 510(k) NO: K121113(TRADITIONAL) ATTN: SHARON ROCKWELL PHONE NO : 727 290 9825 5582 CHALON RD. SE DECISION MADE: 12-JUL-12 YORBA LINDA FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE ARTHOCARE CORPORATION 510(k) NO: K121306(TRADITIONAL) ATTN: CHERYL FREDERICK PHONE NO : 512 358 5751 7000 WEST WILLIAM CANNON DRIVE BUISE DECISION MADE: 12-JUL-12 AUSTIN TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSON ELECTRODE RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K121347(TRADITIONAL) ATTN: JAMES MEWBORNE PHONE NO : 803 252 1222 1140 FIRST ST. SOUTH SE DECISION MADE: 12-JUL-12 Columbia SC 29209 510(k) STATEMENT DEVICE: BW685, BW685S BIEGLER GMBH 510(k) NO: K121198(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR SE DECISION MADE: 12-JUL-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENAISSANCE MAZOR ROBOTICS LTD 510(k) NO: K120812(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976700 02 20 HATA'AS ST. BOX 124 SUITE 213 BSE DECISION MADE: 12-JUL-12 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RI MSC (MIGRATION SEDIMENTATION CHAMBER) RESEARCH INSTRUMENTS LTD. 510(k) NO: K112413(TRADITIONAL) ATTN: DAVID LANSDOWNE PHONE NO : 44 132 6372753 BICKLAND INDUSTRIAL PARK SE DECISION MADE: 13-JUL-12 FALMOUTH, CORNWALL UK TR11 4TA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL 510(k) NO: K120402(TRADITIONAL) ATTN: ELISA HEBB PHONE NO : 650 321 9903 1455 ADAMS DRIVE, #1170 SE DECISION MADE: 13-JUL-12 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK FOCUS DIAGNOSTICS, INC. 510(k) NO: K120413(TRADITIONAL) ATTN: TARA VIVIANI PHONE NO : 562 240 6115 11331 Valley View Street SE DECISION MADE: 13-JUL-12 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR SEEBREATH AB 510(k) NO: K112840(TRADITIONAL) ATTN: ANETTE SJOGREN PHONE NO : 460 462 5358 MORKULLEVAGEN 31 SE DECISION MADE: 13-JUL-12 BJARRED SW 23736 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANCET MICROPOINT TECHNOLOGIES PTE LTD 510(k) NO: K113513(TRADITIONAL) ATTN: CHEE Y LIM PHONE NO : 656 777 0573 11, KALLANG PLACE #06-10/12 SE DECISION MADE: 13-JUL-12 SINGAPORE SN 339155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD 510(k) NO: K113192(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 13-JUL-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, TOSAMA D.O.O. 510(k) NO: K120481(SPECIAL) ATTN: MARJETKA KRALJ KUNCIC PHONE NO : 386 172 90370 SARANOVICEVA CESTA 035 SE DECISION MADE: 13-JUL-12 VIR, DOMZALE SI 1230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113374(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 13-JUL-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXITIME MONOPHASE PRO SCAN HERAEUS KULZER, LLC 510(k) NO: K113574(TRADITIONAL) ATTN: CHRIS HOLDEN PHONE NO : 574 299 5400 300 HERAEUS WAY SE DECISION MADE: 13-JUL-12 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONICA AN24 MONICA HEALTHCARE LTD. 510(k) NO: K112390(TRADITIONAL) ATTN: IAN HOW PHONE NO : 44 115 9124540 BIOCITY, PENNYFOOT STREET SE DECISION MADE: 13-JUL-12 NOTTINGHAM UK NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES LSI SOLUTIONS, INC. 510(k) NO: K111014(TRADITIONAL) ATTN: JUDE S SAUER, M.D. PHONE NO : 585 869 6608 7796 VICTOR-MENDON RD. SE DECISION MADE: 13-JUL-12 NEW YORK NY 14564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE ACUMED LLC 510(k) NO: K120903(SPECIAL) ATTN: BRITTANY CUNNINGHAM PHONE NO : 503 207 1467 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 13-JUL-12 HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPNOGRAPHY PAD (92516) SPACELABS HEALTHCARE 510(k) NO: K121017(SPECIAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 P.O. BOX 3018 SE DECISION MADE: 13-JUL-12 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE MEDTRONIC INC. 510(k) NO: K121767(SPECIAL) ATTN: MARY E DONLIN PHONE NO : 763 526 9172 8200 CORAL SEA STREET NE SE DECISION MADE: 13-JUL-12 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) ANGIOTECH 510(k) NO: K120827(TRADITIONAL) ATTN: KIRSTEN STOWELL PHONE NO : 610 404 1000 100 DENNIS DRIVE SE DECISION MADE: 13-JUL-12 READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC 510(k) NO: K121733(SPECIAL) ATTN: REBECCA K PINE PHONE NO : 760 809 5178 1601 Elm St Ste 300 SE DECISION MADE: 13-JUL-12 Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER ACTA MEDICAL LLC 510(k) NO: K121161(TRADITIONAL) ATTN: AARON COMPTON PHONE NO : 214 533 1416 929 ARBOR DOWNS SR SE DECISION MADE: 13-JUL-12 PLANO TX 75023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESIN 11 RESPINNOVATION SAS 510(k) NO: K121170(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 13-JUL-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL 510(k) NO: K121745(SPECIAL) ATTN: JILL MUNSINGER PHONE NO : 763 225 8500 13355 10TH AVE N, SUITE #110 SE DECISION MADE: 13-JUL-12 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGNET TELEHEALTH MANAGER VIGNET INC. 510(k) NO: K113446(TRADITIONAL) ATTN: CARLOS GONZALEZ PHONE NO : 925 209 6605 7833 KNOLLBROOK DR. SE DECISION MADE: 16-JUL-12 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3MP COLOR LCD MONITOR, RADIFORCE RX340 EIZO NANAO CORPORATION 510(k) NO: K113562(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, HAKUSAN SE DECISION MADE: 16-JUL-12 ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIO 7 BIONET CO., LTD. 510(k) NO: K113306(TRADITIONAL) ATTN: MARC GOODMAN PHONE NO : 949 398 5222 5405 ALTON PARKWAY, SUITE A530 SE DECISION MADE: 16-JUL-12 IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTRAIL III GUIDING CATHETER TERUMO CORPORATION 510(k) NO: K113335(SPECIAL) ATTN: MARK UNTERREINER PHONE NO : 410 392 7213 44-1, 2-CHOME HATAGAYA SE DECISION MADE: 16-JUL-12 SHIBUYA-KU TOKYO JA 151-0072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) ELCAM MEDICAL A.C.A.L. 510(k) NO: K120253(TRADITIONAL) ATTN: AHARON COHEN PHONE NO : 972 469 88120/1/2 KIBBUTZ BAR-AM SE DECISION MADE: 16-JUL-12 D.N. MEROM HAGALIL IS 13860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALYPSO SYSTEM HOGAN LOVELLS US LLP 510(k) NO: K120564(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST 29TH FL SE DECISION MADE: 16-JUL-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE ETHICON ENDO-SURGERY, LLC 510(k) NO: K121600(TRADITIONAL) ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK ROAD SE DECISION MADE: 16-JUL-12 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA HSINER COMPANY 510(k) NO: K120920(TRADITIONAL) ATTN: TOM SHANKS PHONE NO : 951 506 2674 29201 VIA NORTE SE DECISION MADE: 16-JUL-12 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTOMY IRRIGATION SET COLOPLAST A/S 510(k) NO: K121833(SPECIAL) ATTN: TIM CRABTREE PHONE NO : 612 302 4922 1601 WEST RIVER ROAD N SE DECISION MADE: 16-JUL-12 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM SPECTRA SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K121160(TRADITIONAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PARKWAY SE DECISION MADE: 16-JUL-12 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER CHANGZHOU KANGDI MEDICAL STAPLER C510(k) NO: K121474(TRADITIONAL) ATTN: CHARLES MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 16-JUL-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K121837(SPECIAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BLVD SE DECISION MADE: 16-JUL-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS POLYMED THERAPEUTICS, INC 510(k) NO: K112101(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949 951 3046 27001 LA PAZ ROAD, SUITE 266B SE DECISION MADE: 17-JUL-12 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHECK COMBO SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K111353(ABBREVIATED) ATTN: SCOTT THIEL PHONE NO : 317 274 1100 9115 HAGUE ROAD SE DECISION MADE: 17-JUL-12 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A&J 5L POCA SERIES OXYGEN CONCENTRATOR ZHONGSHAN A&J MEDICAL EQUIPMENT CO510(k) NO: K121531(TRADITIONAL) ATTN: JUNHONG AN PHONE NO : 867 602 3130562 3 SHENGHUI SOUTH ROAD NANTOU TOWN,SE DECISION MADE: 17-JUL-12 GUANGDONG CH 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TIO2MESH TM BIOCER ENTWICKLUNGS GMBH 510(k) NO: K113311(TRADITIONAL) ATTN: CHERYL FISHER PHONE NO : 408 410 5920 611 WEST 5TH ST. THIRD FLOOR SE DECISION MADE: 17-JUL-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K121832(SPECIAL) ATTN: CASEY HUGHES PHONE NO : 801 316 4932 1600 WEST MERIT PKWY. SE DECISION MADE: 17-JUL-12 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMAX PEDIATRIC EE TOTAL FACE MASK RESPIRONICS, INC. 510(k) NO: K120562(TRADITIONAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 17-JUL-12 PITTSBURGH PA 15239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI MICROCATHETER NAVILYST MEDICAL, INC. 510(k) NO: K121954(SPECIAL) ATTN: WANDA CARPINELLA PHONE NO : 508 658 7929 26 FOREST STREET SE DECISION MADE: 17-JUL-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CONTACT CLINICAL THERMOMETER RADIANT INNOVATION INC. 510(k) NO: K121428(TRADITIONAL) ATTN: JAMES HUANG PHONE NO : 886 3 6111666 1F, NO.3, INDUSTRIAL E. 9TH RD SCISE DECISION MADE: 17-JUL-12 HSINCHU TW 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIDIAN CRANIAL PERFORATOR ADEOR MEDICAL TECHNOLOGIES GMBH 510(k) NO: K121253(TRADITIONAL) ATTN: FABIO VON ZEPPELIN PHONE NO : 004 908 974442398 KIRCHPLATZ 1 SE DECISION MADE: 17-JUL-12 PULLACH GM 82049 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K120366(ABBREVIATED) ATTN: MARKUS STACHA PHONE NO : 497 031 4632842 HEWLETT-PACKARD STR.2 SE DECISION MADE: 18-JUL-12 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNECTED CARE MOBILE APPLICATION WATERMARK MEDICAL 510(k) NO: K120325(TRADITIONAL) ATTN: MICHAEL J LEIGH PHONE NO : 262 957 6797 12715 FALCON DRIVE SE DECISION MADE: 18-JUL-12 BROOKFIELD WI 53005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 ACETABULAR CUP, PLASMA SPRAY UNITED ORTHOPEDIC CORP. 510(k) NO: K121777(SPECIAL) ATTN: FANG-YUAN HO PHONE NO : 886 3 5773351 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 18-JUL-12 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW SYNERGY PORT LEXION MEDICAL, LLC. 510(k) NO: K120640(TRADITIONAL) ATTN: BERNARD HORWATH PHONE NO : 651 361 8041 5000 TOWNSHIP PKWY SE DECISION MADE: 18-JUL-12 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC. 510(k) NO: K121671(TRADITIONAL) ATTN: DAVID PADGETT PHONE NO : 512 533 1998 5301 Riata Park Court, Building F SE DECISION MADE: 18-JUL-12 AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL 510(k) NO: K121115(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 18-JUL-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE MEDICREA INTERNATIONAL 510(k) NO: K121323(TRADITIONAL) ATTN: LAURE AVIRON-VIOLET PHONE NO : 33 4 72018787 14 Porte du Grand Lyon SE DECISION MADE: 18-JUL-12 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.9MM REELX STT SUTURE ANCHOR SYSTEM STRYKER CORP. 510(k) NO: K120824(TRADITIONAL) ATTN: KELLY KUCHARCZYK PHONE NO : 201 831 6455 3201 E. 3RD AVE SE DECISION MADE: 18-JUL-12 DENVER CO 80206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER EXTREMITY MEDICAL LLC 510(k) NO: K121349(SPECIAL) ATTN: JAMY GANNOE PHONE NO : 973 588 8980 300 INTERPACE PARKWAY SUITE 410 SE DECISION MADE: 18-JUL-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST80I STRESS TEST SYSTEM PHILIPS HEALTHCARE 510(k) NO: K121638(TRADITIONAL) ATTN: GRETAL LUMLEY PHONE NO : 805 214 5101 1525 RANCHO CONEJO BLVD SUITE 100 SE DECISION MADE: 18-JUL-12 THOUSAND OAKS CA 91320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC 510(k) NO: K121417(SPECIAL) ATTN: JAMY GANNOE PHONE NO : 973 588 8980 300 INTERPACE PARKWAY SUITE 410 SE DECISION MADE: 18-JUL-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIO PATCH IRHYTHM TECHNOLOGIES, INC. 510(k) NO: K121319(TRADITIONAL) ATTN: MICHAEL RIGHTER PHONE NO : 415 632 5738 650 TOWNSEND STREET SUITE 380 SE DECISION MADE: 18-JUL-12 SAN FRANCISCO CA 94103 510(k) STATEMENT DEVICE: WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K121355(TRADITIONAL) ATTN: REN YUNHUA PHONE NO : 865 718195 7767 WEST LAKE ECONOMY & TECHNOLOGY ZONSE DECISION MADE: 18-JUL-12 HANGZHOU, ZHEJIANG CH 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS Q-SWITCH RUBY SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K121162(TRADITIONAL) ATTN: MARK ROHRER PHONE NO : 205 290 8251 105 Citation Court SE DECISION MADE: 18-JUL-12 HOMEWOOD AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPNOSTREAM20P WITH AI/ODI ORIDION MEDICAL 1987 LTD. 510(k) NO: K112368(TRADITIONAL) ATTN: RACHEL WEISSBROD PHONE NO : 972 258 99115 7 HAMARPE STREET, HAR HOTZVIM INDUSE DECISION MADE: 19-JUL-12 JERUSALEM IS 91450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE ALT REAGENT ALFA WASSERMANN 510(k) NO: K113382(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 Henderson Drive SE DECISION MADE: 19-JUL-12 Caldwell NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD ECG MONITOR BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K112622(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 19-JUL-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CFR QUANT UNIVERSITY OF TEXAS MEDICAL SCHOOL510(k) NO: K113754(TRADITIONAL) ATTN: K. LANCE GOULD PHONE NO : 713 500 6611 6431 FANNIN ST. ROOM MSB 4.256 SE DECISION MADE: 19-JUL-12 HOUSTON TX 77030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE HANGZHOU BEVER MEDICAL DEVICES CO.510(k) NO: K111401(TRADITIONAL) ATTN: ALLYSON ZHOU PHONE NO : 86 571 88616630 NO. 8-1, LONGQUAN ROAD CANGQIAN TOSE DECISION MADE: 19-JUL-12 HANGZHOU, ZHEJIANG CH 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) HANGZHOU BEVER MEDICAL DEVICES CO.510(k) NO: K111406(TRADITIONAL) ATTN: ALLYSON ZHOU PHONE NO : 86 571 88616630 NO. 8-1, LONGQUAN ROAD CANGQIAN TOSE DECISION MADE: 19-JUL-12 HANGZHOU, ZHEJIANG CH 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING SMITH & NEPHEW, INC. 510(k) NO: K120211(TRADITIONAL) ATTN: JOHN CONNOR PHONE NO : 901 399 5944 1450 BROOKS RD. SE DECISION MADE: 19-JUL-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. 510(k) NO: K121868(SPECIAL) ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857 250 CAMPUS DRIVE SE DECISION MADE: 19-JUL-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCARE MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K120598(TRADITIONAL) ATTN: ROBERT CASARSA PHONE NO : 414 362 3063 8200 WEST TOWER AVE SE DECISION MADE: 19-JUL-12 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORPATH 200 SYSTEM CORINDUS INC. 510(k) NO: K120834(TRADITIONAL) ATTN: MONA ADVANI PHONE NO : 410 674 2060 5523 RESEARCH PARK DRIVE SUITE 110SE DECISION MADE: 19-JUL-12 BALTIMORE MD 21228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSCRIBE ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC 510(k) NO: K120865(SPECIAL) ATTN: CHARLES MORREALE PHONE NO : 414 354 1600 7865 NORTH 86TH STREET SE DECISION MADE: 19-JUL-12 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM BIOJECT MEDICAL TECHNOLOGIES INC. 510(k) NO: K121270(TRADITIONAL) ATTN: CHRISTINE BREITBACH PHONE NO : 503 692 8001 7180 SW Sandburg St Ste 100 SE DECISION MADE: 19-JUL-12 Tigard OR 97223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) TANGSHAN ZHONGHONG PULIN PLASTIC C510(k) NO: K120970(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1 JIANXIANG YUAN NO.2SE DECISION MADE: 19-JUL-12 BEIJING CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTINUOUS SINGLE CULTURE COMPLETE IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K121572(TRADITIONAL) ATTN: JAYME YAMAGUCHI-OWENS PHONE NO : 949 261 7800 2511 DAIMLER ST SE DECISION MADE: 19-JUL-12 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIDEWIRETM(TRADEMARK PENDING) ACME-MONACO CORP. 510(k) NO: K113162(TRADITIONAL) ATTN: BENJAMIN SWEENEY PHONE NO : 860 224 1349 75 WINCHELL DR. SE DECISION MADE: 20-JUL-12 NEW BRITAIN CT 06052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING C.R. BARD, INC. 510(k) NO: K113229(TRADITIONAL) ATTN: STEPHANIE BAKER PHONE NO : 401 825 8588 100 CROSSINGS BOULEVARD SE DECISION MADE: 20-JUL-12 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE TORQUE DEVICE COEUR, INC. 510(k) NO: K113498(TRADITIONAL) ATTN: DEBRA F MANNING PHONE NO : 615 547 7923 100 PHYSICIANS WAY SUITE 200 SE DECISION MADE: 20-JUL-12 LEBANON TN 37090 510(k) STATEMENT DEVICE: SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V. 510(k) NO: K112389(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 32 163 96280 TECHNOLOGIELAAN 15 SE DECISION MADE: 20-JUL-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAVUE ENTERPRISE SUITE ICAD, INC. 510(k) NO: K121517(SPECIAL) ATTN: MICHAEL A PATZ PHONE NO : 603 882 5200 98 SPIT BROOK ROAD SUITE 100 SE DECISION MADE: 20-JUL-12 NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYBRID ARCTICGEL PAD MEDIVANCE, INC. 510(k) NO: K120849(TRADITIONAL) ATTN: LYNNE ARONSON PHONE NO : 303 926 1917 321 SOUTH TAYLOR AVENUE SUITE 200 SE DECISION MADE: 20-JUL-12 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE ENCORE MEDICAL, L.P. 510(k) NO: K121835(SPECIAL) ATTN: MICHAELA NORRIS PHONE NO : 512 834 6291 9800 METRIC BLVD. SE DECISION MADE: 20-JUL-12 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVACATH SECURE IV CATHETER SYSTEM-18G TANGENT MEDICAL TECHNOLOGIES, INC.510(k) NO: K120839(TRADITIONAL) ATTN: KAY FULLER PHONE NO : 734 527 4060 8170 JACKSON RD, STE A SE DECISION MADE: 20-JUL-12 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CR 10-X DIGITIZER PRACTICAL COMPLIANCE, LLC 510(k) NO: K121948(SPECIAL) ATTN: PHONE NO : P.O. BOX 1927 SE DECISION MADE: 20-JUL-12 BREVARD NC 28712 1927 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) ORTHOFIX INC. 510(k) NO: K121658(TRADITIONAL) ATTN: ALLY BADUEL PHONE NO : 214 937 2000 3451 Plano Parkway SE DECISION MADE: 20-JUL-12 Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMK SPHERE MEDACTA INTERNATIONAL 510(k) NO: K121416(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 20-JUL-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMORE TENS SYSTEM GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K120569(ABBREVIATED) ATTN: BODEN S.P. LAI PHONE NO : 866 288 091799 11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 20-JUL-12 TAN SHUI, TAIPEI HSIEN TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) BOVIE MEDICAL CORPORATION 510(k) NO: K121441(TRADITIONAL) ATTN: RICHARD A KOZLOFF PHONE NO : 727 384 2323 5115 Ulmerton Road -- SE DECISION MADE: 20-JUL-12 Clearwater FL 33760 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER INTEGRA LIFESCIENCE CORPORTATION 510(k) NO: K121159(TRADITIONAL) ATTN: STEVEN PELTIER PHONE NO : 609 936 2309 311 ENTERPRISE DRIVE SE DECISION MADE: 20-JUL-12 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASIAN, 3.5/4.5 CONNECTORS K2M, INC. 510(k) NO: K121808(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 20-JUL-12 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION AMERICAN MEDICAL SYSTEMS 510(k) NO: K121612(SPECIAL) ATTN: NGOC LINH PHAM LATCHMAN PHONE NO : 952 939 7023 10700 BREN ROAD WEST SE DECISION MADE: 20-JUL-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K122010(TRADITIONAL) ATTN: YANG ZHAOHUI PHONE NO : 867 558 1885604 MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 20-JUL-12 SHENZHEN CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY SORIN GROUP ITALIA S.R.L. 510(k) NO: K121229(TRADITIONAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 23-JUL-12 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K121907(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 P.O. BOX 6101, MAILSTAP 514 SE DECISION MADE: 23-JUL-12 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO 5MP BARCO NV 510(k) NO: K121788(TRADITIONAL) ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 23-JUL-12 KORTRIJK BE 8500 510(k) STATEMENT DEVICE: ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K113546(TRADITIONAL) ATTN: MICHAEL LEUTHER PHONE NO : 317 521 3930 9115 HAGUE ROAD SE DECISION MADE: 24-JUL-12 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSION CARE FLIGHT MEDICAL MINDS LLC 510(k) NO: K121376(TRADITIONAL) ATTN: DAVID PLATT PHONE NO : 616 308 2859 11491 78TH AVE. SE DECISION MADE: 24-JUL-12 ALLENDALE MI 49401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2PAK OXYGEN GENERATOR PACIFIC PRECISION PRODUCTS 510(k) NO: K120566(TRADITIONAL) ATTN: GERALD WHITE PHONE NO : 949 727 3844 9671 IRVINE CENTER DRIVE SE DECISION MADE: 24-JUL-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONE-TROL LIQUID CHEMISTRY CONTROLS CONE BIOPRODUCTS 510(k) NO: K121759(ABBREVIATED) ATTN: WILL CONE PHONE NO : 830 379 0197 1012 N Austin St SE DECISION MADE: 24-JUL-12 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLUX/DL MICROLUX/BLU BIO/SCREEN ADDENT, INC. 510(k) NO: K121282(TRADITIONAL) ATTN: JOSHUA FRIEDMAN PHONE NO : 203 778 0200 43 MIRY BROOK RD. SE DECISION MADE: 24-JUL-12 DANBURY CT 06810 510(k) STATEMENT DEVICE: E1 EAR SENSORS MASIMO CORPORATION 510(k) NO: K121912(SPECIAL) ATTN: DAVID COLLETTE PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 24-JUL-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPOTHIXO KERRHAWE SA 510(k) NO: K111465(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 25-JUL-12 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENZZZZZ AWAY CENTRIX, INC. 510(k) NO: K120176(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL STE 200 SE DECISION MADE: 25-JUL-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A J. MORITA USA, INC. 510(k) NO: K120377(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202 783 5070 1425 K STREET NW SUITE 1100 SE DECISION MADE: 25-JUL-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL MAJESTY FLOW KURARAY NORITAKE DENTAL INC. 510(k) NO: K121583(TRADITIONAL) ATTN: KIYOYUKI ARIKAWA PHONE NO : 212 986 2230 33 MAIDEN LANE, 6TH FLOOR SE DECISION MADE: 25-JUL-12 NEW YORK NY 10038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT MEDTRONIC INC. 510(k) NO: K120988(SPECIAL) ATTN: JACQUELINE HAUGE PHONE NO : 763 514 9967 7611 NORTHLAND DRIVE SE DECISION MADE: 25-JUL-12 BROOKLYN PARK MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER NINEPOINT MEDICAL, INC 510(k) NO: K121195(SPECIAL) ATTN: CINDY DOMECUS PHONE NO : 650 343 4813 1171 BARROIHET AVENUE SE DECISION MADE: 25-JUL-12 HILLSBOROUGH CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXITIME FAST & SCAN LIGHT FLOW HERAEUS KULZER, LLC 510(k) NO: K120914(SPECIAL) ATTN: JAMIE MEARNA PHONE NO : 574 299 5421 300 Heraeus Way SE DECISION MADE: 25-JUL-12 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K121557(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SE DECISION MADE: 25-JUL-12 SUITE F GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV ROCHE DIAGNOSTICS 510(k) NO: K120625(TRADITIONAL) ATTN: K. COLLEEN ADAMS PHONE NO : 317 521 3577 9115 HAGUE ROAD SE DECISION MADE: 25-JUL-12 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER CONVATEC INC 510(k) NO: K121275(TRADITIONAL) ATTN: KATRINA FIEDLER PHONE NO : 908 904 2541 200 HEADQUARTERS PARK DRIVE SE DECISION MADE: 25-JUL-12 SKILLMAN NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TL TRISEB CREAM TRIGEN LABORATORIES, INC. 510(k) NO: K121134(TRADITIONAL) ATTN: MELISSA GOODHEAD PHONE NO : 813 671 8570 11705 BOYETTE RD, STE 171 SE DECISION MADE: 25-JUL-12 RIVERVIEW FL 33569 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HLS UNI EVOLUTION & U-KNEETEC TORNIER, INC. 510(k) NO: K120262(TRADITIONAL) ATTN: STEPHANIE BERNARD PHONE NO : 330 476 613500 161, RUE LAVOISIER SAINT ISMIER CESE DECISION MADE: 25-JUL-12 MONTBONNOT FR 38334 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM STRYKER CORP. 510(k) NO: K121252(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 25-JUL-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ZERO-P VARIABLE ANGLE (VA) SYNTHES SPINE CO.LP 510(k) NO: K121852(SPECIAL) ATTN: MONIKA MCDOLE-RUSSELL PHONE NO : 610 719 5448 1302 WRIGHTS LANE EAST SE DECISION MADE: 25-JUL-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K121510(TRADITIONAL) ATTN: SARAH RIZK PHONE NO : 203 492 6339 60 Middletown Ave SE DECISION MADE: 25-JUL-12 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSISEP AND POSISEP X HEMOSTAT DRESSINGS HEMOSTASIS, LLC 510(k) NO: K120958(TRADITIONAL) ATTN: BERNARD HORWATH PHONE NO : 651 855 1466 5000 Township Pkwy SE DECISION MADE: 25-JUL-12 Saint Paul MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETY INFUSION SET GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K121908(SPECIAL) ATTN: JUDITH SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 25-JUL-12 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREGUIDE OXIMETER REFLECTANCE MEDICAL INC 510(k) NO: K113656(TRADITIONAL) ATTN: NANDINI MURTHY PHONE NO : 781 710 5378 116 FLAUNDERS ROAD, SUITE 1000 SE DECISION MADE: 26-JUL-12 WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE USA AVENUE L INTERBODY FUSION LDR SPINE USA INC. 510(k) NO: K113285(TRADITIONAL) ATTN: MARITZA ELIAS PHONE NO : 512 344 3471 13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 26-JUL-12 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE C-ARM CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K121303(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 26-JUL-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIGEN REINFORCED DUAL LUMEN CATHETER ORIGEN BIOMEDICAL 510(k) NO: K113869(TRADITIONAL) ATTN: RICHARD MARTIN PHONE NO : 512 474 7278 7000 BURLESON ROAD BLDG D SE DECISION MADE: 26-JUL-12 AUSTIN TX 78744 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON COLONOSCOPES FUJINON, INC. 510(k) NO: K112391(SPECIAL) ATTN: GINA WALLJASPER PHONE NO : 973 655 5600 10 HIGH POINT DR. SE DECISION MADE: 26-JUL-12 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K113397(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744 200 EVANS WAY SE DECISION MADE: 26-JUL-12 BRANCHBURG NJ 08876 510(k) STATEMENT DEVICE: PIONEER STERNAL ASSIST IMPLANT SYSTEM PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K120016(TRADITIONAL) ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861 375 RIVER PARK CIRCLE SE DECISION MADE: 26-JUL-12 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A/C ENZYMATIC VITAMIN B6 ASSAY ANTICANCER INC 510(k) NO: K111260(TRADITIONAL) ATTN: QINGHONG HAN PHONE NO : 858 654 2555 7917 OSTROW ST. SE DECISION MADE: 26-JUL-12 SAN DIEGO CA 92111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121888(TRADITIONAL) ATTN: DONGHWAN KIM PHONE NO : 827 074 652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 26-JUL-12 SEOUL KS 152-848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS BIOMET CORPORATION 510(k) NO: K121183(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 267 6639 56 EAST BELL DRIVE SE DECISION MADE: 26-JUL-12 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEX VITAL SIGNS MONITOR 6000 SERIES WELCH ALLYN, INC. 510(k) NO: K121013(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 26-JUL-12 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WI-FI BODY SCALE ANDON HEALTH CO., LTD 510(k) NO: K120896(TRADITIONAL) ATTN: LIU YI PHONE NO : 862 260 526161 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 26-JUL-12 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K120993(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 26-JUL-12 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARISCT ICRCO INC. 510(k) NO: K120753(TRADITIONAL) ATTN: GREG WACHTLER PHONE NO : 310 921 9559 2580 WEST 237TH STREET SE DECISION MADE: 26-JUL-12 TORRANCE CA 90505 510(k) STATEMENT DEVICE: CONTOUR NEXT BLOOD GLUCOSE METER BAYER HEALTHCARE LLC 510(k) NO: K121190(SPECIAL) ATTN: CHARLES RYAN PHONE NO : 914 333 6122 555 WHITE PLAINS RD. SE DECISION MADE: 26-JUL-12 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS-SERIES-FP WITH 3030+OPTION OMEGA MEDICAL IMAGING, LLC 510(k) NO: K121293(TRADITIONAL) ATTN: BRIAN J FLEMING PHONE NO : 407 323 9400 675 HICKMAN CIRCLE SE DECISION MADE: 26-JUL-12 Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NERVEVISION SOFTWARE SYSTEMS 3D IMAGING PARTNERS INC. 510(k) NO: K121075(TRADITIONAL) ATTN: CAROLYN PRIMUS PHONE NO : 941 753 9737 7046 OWL'S NEST TERRACE SE DECISION MADE: 26-JUL-12 BRADENTON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER ALL SUTURE ANCHORS STRYKER 510(k) NO: K120509(TRADITIONAL) ATTN: KELLY KUCHARCZYK PHONE NO : 201 831 6455 3201 E. 3RD AVE SE DECISION MADE: 26-JUL-12 DENVER CO 80206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTARGETING XL STAR DRIVE SYSTEM FHC, INC. 510(k) NO: K121950(SPECIAL) ATTN: KERI SEITZ PHONE NO : 207 666 5651 1201 MAIN ST SE DECISION MADE: 26-JUL-12 BOWDOIN ME 04287 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE INNO ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121937(TRADITIONAL) ATTN: DONGHWAN KIM PHONE NO : 827 074 652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 26-JUL-12 SEOUL KS 152-848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S.C.O.R.E.S. UNIT AMMED SURGICAL EQUIPMENT, LLC 510(k) NO: K110898(TRADITIONAL) ATTN: DAVID C FURR PHONE NO : 512 906 9654 8708 CAPEHART COVE SE DECISION MADE: 26-JUL-12 AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR SORIN GROUP ITALIA S.R.L. 510(k) NO: K121909(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 26-JUL-12 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K121922(SPECIAL) ATTN: MERIAM YOUSSEF PHONE NO : 610 930 1800 2460 GENERAL ARMISTEAD AVE. SE DECISION MADE: 26-JUL-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICP TRIAGEMANAGER EMERGO EUROPE CONSULTING BV 510(k) NO: K122095(TRADITIONAL) ATTN: RACHIDA ZIANI PHONE NO : 011 310703 458570 PRINSESSEGRACHT 20 SE DECISION MADE: 26-JUL-12 DEN HAAG NL 2514 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. 510(k) NO: K121512(TRADITIONAL) ATTN: DON WILLIAMS PHONE NO : 847 949 5200 ONE BIOLOGIC PLAZA SE DECISION MADE: 26-JUL-12 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION RXL TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K121553(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DRIVE SE DECISION MADE: 26-JUL-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K121982(SPECIAL) ATTN: LAUREN KAMER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 26-JUL-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALERE PBP2A TEST ALERE SCARBOROUGH, INC 510(k) NO: K121905(SPECIAL) ATTN: ANGELA DRYSDALE PHONE NO : 207 730 5737 10 SOUTHGATE ROAD SE DECISION MADE: 26-JUL-12 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG SHOUGUANG KINGLIYUAN MEDI510(k) NO: K120797(TRADITIONAL) ATTN: KEVIN XU PHONE NO : 312 488 1785 916 WEST 21ST STREET SE DECISION MADE: 27-JUL-12 CHICAGO IL 60608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HC-BIOS DENTAL IMPLANT HUNG CHUN BIO-S CO., LTD. 510(k) NO: K110425(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO.45, MINSHENG RD DANSHUI TOWN SE DECISION MADE: 27-JUL-12 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLATE 5.0 AGGREGOMETER VERUM DIAGNOSTICA GMBH 510(k) NO: K103555(TRADITIONAL) ATTN: MAXIMILIAN ZUCKER PHONE NO : 490 891 255560 REICHENBACHSTRASSE 27 SE DECISION MADE: 27-JUL-12 MUNICH GM 80469 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER PROSPERA CORPORATION 510(k) NO: K113544(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 405 BOULDER CT SUITE 500 SE DECISION MADE: 27-JUL-12 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K113489(TRADITIONAL) ATTN: ANTJE KATZER PHONE NO : 364 177 00309 BRUESSELER STR. 10 SE DECISION MADE: 27-JUL-12 JENA GM 07747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM HMD BIOMEDICAL, INC. 510(k) NO: K113307(TRADITIONAL) ATTN: JESSICA TUNG PHONE NO : 886 3 6017000 No 181 Minsheng St, Xinpu TownshipSE DECISION MADE: 27-JUL-12 Hsinchu County TW 305 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOBEAM HOLMIUM LASER FIBERS C.R. BARD, INC. 510(k) NO: K120926(TRADITIONAL) ATTN: TERRI MORRIS PHONE NO : 770 784 6994 8195 INDUSTRIAL BLVD SE DECISION MADE: 27-JUL-12 COVINGTON GA 30209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EON CHOLESTEROL REAGENT VITAL DIAGNOSTICS PTY. LTD 510(k) NO: K120202(TRADITIONAL) ATTN: MELITA LAMBIRIS PHONE NO : 613 897 36300 189 - 199 BROWNS ROAD SE DECISION MADE: 27-JUL-12 NOBLE PARK, VICTORIA AS 3174 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE SHANDONG TAIXIANG MEDICAL PRODUCTS510(k) NO: K120230(TRADITIONAL) ATTN: RAY ZHOU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 27-JUL-12 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IO-TOME DEVICE BAXANO, INC. 510(k) NO: K113073(TRADITIONAL) ATTN: EDWARD J SINCLAIR PHONE NO : 408 514 2220 655 River Oaks Pkwy SE DECISION MADE: 27-JUL-12 San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEMS 510(k) NO: K121879(SPECIAL) ATTN: JULIE TOM WING PHONE NO : 610 984 9147 3773 CORPORATE PWKY. SE DECISION MADE: 27-JUL-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS 99 ONE, IPS 99 CREAM IVOCLAR VIVADENT AG 510(k) NO: K121359(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 27-JUL-12 AMHERST NY 14228 510(k) STATEMENT DEVICE: MOJO, VERASEAL SLEEPNET CORPORATION 510(k) NO: K120463(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 27-JUL-12 BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM ACCEL SPINE 510(k) NO: K121569(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 27-JUL-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSICARDIAC DIACOUSTIC MEDICAL (PTY) 510(k) NO: K121617(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE SE DECISION MADE: 27-JUL-12 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT OBP CORPORATION 510(k) NO: K121604(TRADITIONAL) ATTN: JASON SWIFT PHONE NO : 888 300 2946 360 MERRIMACK STREET BUILDING 9 SE DECISION MADE: 27-JUL-12 LAWRENCE MA 01843 510(k) STATEMENT DEVICE: ZEOBI IVIVI HEALTH SCIENCE, LLC 510(k) NO: K121338(SPECIAL) ATTN: KATHRYN CLUBB PHONE NO : 415 814 2460 330 TOWNSEND STREET SUITE 100 SE DECISION MADE: 27-JUL-12 SAN FRANCISCO CA 94107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL ACCESS SCIENTIFIC, INC. 510(k) NO: K121748(SPECIAL) ATTN: ALBERT MISAJON PHONE NO : 858 259 8333 12526 HIGH BLUFF DRIVE SUITE 360 SE DECISION MADE: 27-JUL-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. 510(k) NO: K121897(SPECIAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 27-JUL-12 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPRESSWAY RX CATHETER (6F LD-VERISON) KANEKA PHARMA AMERICA LLC 510(k) NO: K121301(SPECIAL) ATTN: JOSEPH DEPAOLO PHONE NO : 603 880 1433 546 FIFTH AVE., 21ST FLOOR SE DECISION MADE: 30-JUL-12 New York NY 10036 510(k) STATEMENT DEVICE: KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT KEVO MEDICAL SUPPLIES 510(k) NO: K113199(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 30-JUL-12 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K120467(TRADITIONAL) ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 30-JUL-12 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST IND NDIAGNOSTIC INC. 510(k) NO: K121231(TRADITIONAL) ATTN: KAI LOU PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 30-JUL-12 DELTA, BRITISH COLUMBIA CA V3M 510(k) STATEMENT DEVICE: DYNASTY BIOFOAM SHELL WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K121544(TRADITIONAL) ATTN: YUAN LI PHONE NO : 901 867 4146 5677 AIRLINE RD. SE DECISION MADE: 30-JUL-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL C-RAD POSITIONING AB 510(k) NO: K120668(TRADITIONAL) ATTN: JANINA OSTLING PHONE NO : 461 866 6930 BREDGRAND 18 SE DECISION MADE: 30-JUL-12 UPPSALA SW 75320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAPBV BODY SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121292(TRADITIONAL) ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 30-JUL-12 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATO MICROCATH 27 MICROCATHETER SCIENTIA VASCULAR , LLC 510(k) NO: K121734(TRADITIONAL) ATTN: SHARON ROCKWELL PHONE NO : 714 695 9269 2700 SOUTH 900 WEST SUITE D SE DECISION MADE: 30-JUL-12 SALT LAKE CITY UT 84119 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM LETO ENTERPRISE LTD. 510(k) NO: K120511(TRADITIONAL) ATTN: SABRINA WEI PHONE NO : 867 558 3089699 308 HENNESSY RD SE DECISION MADE: 30-JUL-12 WANCHAI HK HONGKONG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD SAFE ORTHOPAEDICS 510(k) NO: K121299(TRADITIONAL) ATTN: PIERRE DUMOUCHEL PHONE NO : 330 134 215000 Parc des Bellevues Allee R.LuxemboSE DECISION MADE: 30-JUL-12 Eragny sur Oise FR 95610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIP SYSTEMS HOWMEDICA OSTEONICS CORP 510(k) NO: K121308(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201 831 5718 325 CORPORATE DR. SE DECISION MADE: 30-JUL-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STENTUBE LACRIMAL INTUBATION SET QUEST MEDICAL, INC. 510(k) NO: K113118(SPECIAL) ATTN: AMY CLENDENING-WHEELER PHONE NO : 972 332 6338 ONE ALLENTOWN PKWY. SE DECISION MADE: 31-JUL-12 ALLEN TX 75002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOSPEED PLUS ASTRA TECH AB 510(k) NO: K120414(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 31-JUL-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HQS INTRODUCER ALSEAL 510(k) NO: K113849(TRADITIONAL) ATTN: JEAN-FRANCOIS DELFORGE PHONE NO : 330 381 616993 ESPACE VALENTIN- VALPARC 6C, RUE DSE DECISION MADE: 31-JUL-12 BESANCON FR 25048 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM INOVA DIAGNOSTICS, INC. 510(k) NO: K112545(TRADITIONAL) ATTN: MICHAEL MAHLER PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 31-JUL-12 SAN DIEGO CA 92131 1638 510(k) STATEMENT DEVICE: DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT NOVOCOL, INC. 510(k) NO: K120283(ABBREVIATED) ATTN: CORA BRACHO-TROSONIS PHONE NO : 303 665 7535 416 SOUTH TAYLOR AVE. SE DECISION MADE: 31-JUL-12 LOUISVILLE CO 80027 510(k) STATEMENT DEVICE: VIDAS D-DIMER EXCLUSION II (DEX2) BIOMERIEUX, INC. 510(k) NO: K112818(TRADITIONAL) ATTN: VERONICA DAENZER PHONE NO : 314 731 8573 595 ANGLUM RD. SE DECISION MADE: 31-JUL-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICTUS LASER PLATFORM TECHNOLAS PERFECT VISION GMBH 510(k) NO: K120426(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 415 297 0408 1025 SANCHEZ STREET SE DECISION MADE: 31-JUL-12 SAN FRANCISCO CA 94114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME HOMOCYSTEINE POC TEST KIT DIAZYME LABORATORIES 510(k) NO: K121053(TRADITIONAL) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 31-JUL-12 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATOM 1 (MODEL: BRC 2200) BIOELECTRIC RESEARCH CORPORATION 510(k) NO: K121578(TRADITIONAL) ATTN: STEVEN KAYE PHONE NO : 775 884 1200 112 N. CURRY STREET SE DECISION MADE: 31-JUL-12 CARSON CITY NV 89703 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNTHES MATRIX SYSTEM SYNTHES SPINE 510(k) NO: K120838(TRADITIONAL) ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LANE EAST SE DECISION MADE: 31-JUL-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 267 TOTAL WITH SUMMARIES 247 TOTAL WITH STATEMENTS 20
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