Medical Devices
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October 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2011 DEVICE: CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE CHIENMAX VIETNAM CO. LTD 510(k) NO: K103675(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-OCT-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELLAGEN TISSUE REPAIR COMPANY 510(k) NO: K110318(TRADITIONAL) ATTN: LOIS CHANDLER PHONE NO : 858 436 1012 12255 EL CAMINO REAL SUITE 250 SE DECISION MADE: 03-OCT-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETWO SKIN TREATMENT SYSTEM SYNERON, LTD. 510(k) NO: K110672(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 03-OCT-11 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF KWANG MYUNG DAICOM INC 510(k) NO: K111169(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 03-OCT-11 FULLERTON CA 92833 510(k) STATEMENT DEVICE: PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K110308(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 03-OCT-11 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER CARE ANITBACTERIAL TOOTHBRUSH PIAVE SPAZZOLIFICIO S.P.A. 510(k) NO: K102871(TRADITIONAL) ATTN: KEILA LACOURT PHONE NO : 917 674 0418 212 W 91ST ST APT 812 SE DECISION MADE: 03-OCT-11 NEW YORK NY 10024 510(k) STATEMENT DEVICE: PINNACLE PRECISION ACCESS SYSTEM TERUMO MEDICAL CORP. 510(k) NO: K111606(TRADITIONAL) ATTN: DANIEL R PLONSKI PHONE NO : 410 392 7395 950 ELKTON BLVD. SE DECISION MADE: 03-OCT-11 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM STRAUMANN USA 510(k) NO: K111357(TRADITIONAL) ATTN: ELAINE ALAN PHONE NO : 978 747 2513 60 MINUTEMAN ROAD SE DECISION MADE: 03-OCT-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARMADA 35/35LL PTA CATHETER ABBOTT VASCULAR 510(k) NO: K111899(TRADITIONAL) ATTN: LAARNI RICAFORT PHONE NO : 408 845 0688 3200 LAKESIDE DRIVE SE DECISION MADE: 03-OCT-11 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER ENCORE MEDICAL, L.P. 510(k) NO: K111735(TRADITIONAL) ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 03-OCT-11 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STREPTOCOCCUS LEVOFLOXACIN BIOMERIEUX, INC. 510(k) NO: K112228(TRADITIONAL) ATTN: JENNIFER CHIA-HSUAN LIN PHONE NO : 314 731 8639 595 ANGLUM RD. SE DECISION MADE: 03-OCT-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBICATH TRANSSEPTAL NEEDLE GREATBATCH MEDICAL 510(k) NO: K111644(TRADITIONAL) ATTN: KRISTI FOX PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 03-OCT-11 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K103487(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 04-OCT-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K110870(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DR. P.O. BOX 2068 SE DECISION MADE: 04-OCT-11 TUSTIN CA 92781 2068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K110063(TRADITIONAL) ATTN: MIKE SCOTT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 04-OCT-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOMED CARDIO MEDICAL PRODUCTS, INC. 510(k) NO: K103651(TRADITIONAL) ATTN: NICK MENDISE PHONE NO : 973 586 9500 385 FRANKLIN AVE. STE. L SE DECISION MADE: 04-OCT-11 ROCKAWAY NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECO DIAGNOSTICS SALIVA ALCOHOL TEST TECO DIAGNOSTICS 510(k) NO: K111206(TRADITIONAL) ATTN: JAMES LI PHONE NO : 714 463 1111 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 04-OCT-11 ANAHEIM CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXIMETRY INTERFACE KIT PHILIPS RESPIRONICS, INC 510(k) NO: K111378(TRADITIONAL) ATTN: ELAINE LARKIN PHONE NO : 724 387 5350 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 04-OCT-11 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OEC(R) 9800, OEC(R) 9800 PLUS GE OEC MEDICAL SYSTEMS, INC 510(k) NO: K111551(TRADITIONAL) ATTN: GERALD BUSS PHONE NO : 801 517 6591 384 WRIGHT BROTHERS DR. SE DECISION MADE: 04-OCT-11 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHAKER DIGITAL THERMOMETER MEASURE TECHNOLOGY CO. LTD. 510(k) NO: K112703(SPECIAL) ATTN: RACK YU PHONE NO : 886 285 122747 7F, NO 86, SEC. 1, KWANG FU RD SE DECISION MADE: 04-OCT-11 SAN CHUNG CITY, TAIPEI HSIANG T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAATZ 560 DRTECH CORP. 510(k) NO: K111583(SPECIAL) ATTN: CHOUL-WOO SHIN PHONE NO : 82 31 7306823 333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 04-OCT-11 SEONGNAM-SHI, GYEONGGI-DO KS 46510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K111905(ABBREVIATED) ATTN: MARKUS STACHA PHONE NO : 49 70 314632842 HEWLETT-PACKARD STR.2 SE DECISION MADE: 04-OCT-11 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT TELEFLEX MEDICAL, INC. 510(k) NO: K112456(SPECIAL) ATTN: NATALIE SMITH PHONE NO : 919 433 8049 2917 WECK DR. SE DECISION MADE: 04-OCT-11 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOTRAIN CURAFLOW BAUERFEIND AG 510(k) NO: K111662(TRADITIONAL) ATTN: INES EXNER PHONE NO : 49 366 28661350 TRIEBESER STRASSE 16 SE DECISION MADE: 04-OCT-11 ZEULENRODA-TRIEBES GM 07937 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL CLINICAL THERMOMETER MODEL V901US AMPEROR-ELECTRONIC(SZ) CO., LTD 510(k) NO: K112116(SPECIAL) ATTN: RAJ KASBEKAR PHONE NO : 508 490 7280 250 TURNPIKE ROAD SE DECISION MADE: 04-OCT-11 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PERIARTICULAR SCREWS ZIMMER INC. 510(k) NO: K111447(TRADITIONAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944 P.O. BOX 708 SE DECISION MADE: 05-OCT-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGHMED ROOLIP MANIPULATOR J.SINGH INSTRUMENTS 510(k) NO: K110819(TRADITIONAL) ATTN: CAROLINE TONTINI PHONE NO : 512 327 9997 611 WEST 5TH STREET 3RD FLOOR SE DECISION MADE: 05-OCT-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION AMERIWATER 510(k) NO: K111740(ABBREVIATED) ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833 1303 STANLEY AVE. SE DECISION MADE: 05-OCT-11 DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXETER X3 RIMFIT ACETABULAR CUP STRYKER CORP. 510(k) NO: K111848(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 05-OCT-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEACELABS MULTIGAS MODULE SPACELABS HEALTHCARE 510(k) NO: K112173(SPECIAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 P.O. BOX 3018 SE DECISION MADE: 05-OCT-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 BIOSENSE WEBSTER, INC. 510(k) NO: K112007(SPECIAL) ATTN: WAYNE R HOHMAN PHONE NO : 909 839 8597 3333 DIAMOND CANYON RD SE DECISION MADE: 05-OCT-11 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLEMAX FAMILY OF LASERS CANDELA CORP. 510(k) NO: K112715(TRADITIONAL) ATTN: SAM WADE PHONE NO : 508 358 7400 530 BOSTON POST ROAD SE DECISION MADE: 05-OCT-11 WAYLAND MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM CHENG MEDICAL, CORPORATION 510(k) NO: K101592(TRADITIONAL) ATTN: MARY P GALLUP PHONE NO : 510 441 4017 12945 SARATOGA AVE SE DECISION MADE: 06-OCT-11 SARATOGA CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENOGRAPH DS, SENOGRAPH ESSENSTIAL GENERAL ELECTRIC COMPANY 510(k) NO: K103485(TRADITIONAL) ATTN: STEVEN KACHELMEYER PHONE NO : 262 548 2432 3000 N. GRANDVIEW BLVD., W-709 SE DECISION MADE: 06-OCT-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOFLIP ECD CROSPON, LTD. 510(k) NO: K110531(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 06-OCT-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS ABBOTT LABORATORIES 510(k) NO: K110579(TRADITIONAL) ATTN: DARLA ABANO PHONE NO : 847 937 3461 100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 06-OCT-11 ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYLOCK OSTEOSYSTEM TRIMED, INC. 510(k) NO: K111266(TRADITIONAL) ATTN: DOUG STEINBERGER PHONE NO : 661 255 7406 27533 AVENUE HOPKINS SE DECISION MADE: 06-OCT-11 SANTA CLARITA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) ASCOT TECHNOLOGIES, INC. 510(k) NO: K103643(ABBREVIATED) ATTN: MARY E RANDALL PHONE NO : 919 388 1776 267 HOGANS VALLEY WAY SE DECISION MADE: 06-OCT-11 CARY NC 27513 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRYVIEW CHROMA IMAGING SYSTEM CARESTREAM HEALTH,INC. 510(k) NO: K111566(TRADITIONAL) ATTN: CHRISTINE EHAMNN PHONE NO : 585 627 6473 150 VERONA STREET SE DECISION MADE: 06-OCT-11 ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. 510(k) NO: K112037(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 06-OCT-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XL EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K112571(SPECIAL) ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 06-OCT-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C2 NERVEMONITOR SYSTEM WITH ACCESSORIES INOMED MEDIZINTECHNIK GMBH 510(k) NO: K111647(TRADITIONAL) ATTN: SASCHKA BUSCH PHONE NO : 49 764 1941487 IM HAUSGRUEN 29 SE DECISION MADE: 06-OCT-11 EMMENDINGEN GM 79312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS CROSSTEX INTERNATIONAL, INC. 510(k) NO: K111343(TRADITIONAL) ATTN: RICHARD M ORMSBEE PHONE NO : 763 551 2689 14605 28TH AVENUE NORTH SE DECISION MADE: 06-OCT-11 MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K103625(TRADITIONAL) ATTN: JOYCE KILROY PHONE NO : 215 660 2626 3135 QUARRY RD. SE DECISION MADE: 06-OCT-11 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. 510(k) NO: K111371(TRADITIONAL) ATTN: QIYI XIE PHONE NO : 858 875 8011 10125 MESA RIM RD. SE DECISION MADE: 06-OCT-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILDCAT 5F GUIDEWIRE SUPPORT CATHETER AVINGER, INC. 510(k) NO: K112579(SPECIAL) ATTN: SEVRINA CIUCCI PHONE NO : 650 241 7900 400 CHESAPEAKE DRIVE SE DECISION MADE: 06-OCT-11 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) SIEMENS HEATLHCARE DIAGNOSTICS INC510(k) NO: K102772(TRADITIONAL) ATTN: HELEN M LEE PHONE NO : 302 631 8706 500 GBC DRIVE M/S 514 SE DECISION MADE: 07-OCT-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY ZIMMER GMBH 510(k) NO: K110836(TRADITIONAL) ATTN: DANIEL J WILLIMAN PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 07-OCT-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II ELITECH GROUP 510(k) NO: K110780(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 825 5174 21720 23RD DR S.E., SUITE 150 SE DECISION MADE: 07-OCT-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM BROADMASTER BIOTECH CORPORATION 510(k) NO: K102316(TRADITIONAL) ATTN: ROGER LAI PHONE NO : 886 266 375859 7F, NO. 168-2, LIANCHENG SE DECISION MADE: 07-OCT-11 ZHONGHE CITY TW 23553 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K111320(TRADITIONAL) ATTN: JON WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 07-OCT-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABI PLUS INFANT NASAL CANNULA SYSTEM A PLUS MEDICAL 510(k) NO: K110471(SPECIAL) ATTN: THOMAS C LOESCHER PHONE NO : 760 930 0425 5431 AVENIDA ENCINAS SUITE G SE DECISION MADE: 07-OCT-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE LARSON MEDICAL PRODUCTS, INC. 510(k) NO: K112460(TRADITIONAL) ATTN: PETER LARSON PHONE NO : 740 788 8107 80 WESTGATE DRIVE SE DECISION MADE: 07-OCT-11 NEWARK OH 43055 510(k) STATEMENT DEVICE: HUIBAO BODY FAT SCALE ZHONGSHAN HUIBAO WEIGHING APPARATU510(k) NO: K111404(TRADITIONAL) ATTN: KEVIN DENG PHONE NO : 867 602 3668989 CHANGAN ROAD, GUZHEN TOWN SE DECISION MADE: 07-OCT-11 ZHONGSHAN CITY, GUANGDONG CH 52510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL INC. 510(k) NO: K111859(TRADITIONAL) ATTN: AMY MCKINNEY PHONE NO : 651 287 5096 63 CHICORY CT. SE DECISION MADE: 07-OCT-11 LAKE JACKSON TX 77566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION FLOW(R) - HELIOX VAPOTHERM, INC. 510(k) NO: K111640(TRADITIONAL) ATTN: GREGORY A WHITNEY PHONE NO : 410 604 0808 198 LOG CANOE CIRCLE SE DECISION MADE: 07-OCT-11 STEVENSVILLE MD 21666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC(TM) BONE SCREWS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K112772(SPECIAL) ATTN: KELLEN HILLS PHONE NO : 901 290 5816 5677 AIRLINE RD. SE DECISION MADE: 07-OCT-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORP. 510(k) NO: K112635(SPECIAL) ATTN: SWARNA MUKUND PHONE NO : 770 587 8083 1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 07-OCT-11 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) ACCLARENT, INC. 510(k) NO: K110687(SPECIAL) ATTN: DEAN KNIGHT PHONE NO : 650 687 4087 1525-B O'BRIEN DR. SE DECISION MADE: 07-OCT-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY INTUITIVE SURGICAL, INC. 510(k) NO: K112263(SPECIAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 07-OCT-11 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE ANTHOGYR SAS 510(k) NO: K111532(TRADITIONAL) ATTN: BRAYETTE SABINE PHONE NO : 334 505 80237 2237, AVENUE ANDRE LASQUIN SE DECISION MADE: 07-OCT-11 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED HAND FUSION SYSTEM OSTEOMED L.P. 510(k) NO: K111419(TRADITIONAL) ATTN: SUZANNE CHEANG PHONE NO : 972 677 4779 3885 ARAPAHO RD. SE DECISION MADE: 07-OCT-11 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS GLOBUS MEDICAL, INC. 510(k) NO: K112756(SPECIAL) ATTN: KELLY J BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 07-OCT-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS SWAN SYSTEM VENUS CONCEPT LTD 510(k) NO: K111784(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST SE DECISION MADE: 07-OCT-11 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MECTACER BIOLOX(R) DELTA FEMORAL HEADS MEDACTA USA, INC. 510(k) NO: K112115(SPECIAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 Calle Quetzal Unit B SE DECISION MADE: 07-OCT-11 Camarillo CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOMOTHERAPY TREATMENT SYSTEM TOMOTHERAPY INCORPORATED 510(k) NO: K112446(TRADITIONAL) ATTN: GREG BANGE PHONE NO : 608 830 3605 1209 DEMING WAY SE DECISION MADE: 07-OCT-11 MADISON WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCORDE BULLET SPINAL SYSTEM JOHNSON & JOHNSON 510(k) NO: K110694(SPECIAL) ATTN: DAPHNEY GERMAIN-KOLAWOLE PHONE NO : 508 880 8395 325 PARAMOUNT DR. SE DECISION MADE: 11-OCT-11 RAYNHAM MA 02767 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTH-E-CONNECT SYSTEM ALR TECHNOLOGIES 510(k) NO: K102063(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 11-OCT-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K112615(SPECIAL) ATTN: BRAHIM HADRI PHONE NO : 781 249 8030 7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 11-OCT-11 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEVA SPIN SINUS DILATION SYSTEM ACCLARENT, INC. 510(k) NO: K111875(TRADITIONAL) ATTN: KERI YEN PHONE NO : 650 687 5874 1525-B O'BRIEN DR. SE DECISION MADE: 11-OCT-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAUMEDIC ICP MONITORING SYSTEM RAUMEDIC AG 510(k) NO: K112017(TRADITIONAL) ATTN: REINER THIEM PHONE NO : 499 25 523592782 HERRMANN-STAUDINGER-STR. 2 SE DECISION MADE: 11-OCT-11 HELMBRECHTS GM D 95233 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. 510(k) NO: K112254(TRADITIONAL) ATTN: SCOTT LIANG PHONE NO : 862 082 986918 25 YONGHUA, YONGHE, GETDD SE DECISION MADE: 11-OCT-11 GUANGZHOU, GUANGDONG CH CN-5113510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW CANNULATED SCREWS AND WASHERS SMITH & NEPHEW, INC. 510(k) NO: K111994(TRADITIONAL) ATTN: MAUREEN WHITSON PHONE NO : 901 399 6845 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 11-OCT-11 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONSET ACCESS CATHETER SYSTEM ONSET MEDICAL CORPORATION 510(k) NO: K112629(TRADITIONAL) ATTN: JOSEPH BISHOP PHONE NO : 949 716 1100 13900 ALTON PARKWAY, SUITE 120 SE DECISION MADE: 11-OCT-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESIGNS VS2+ -SURESIGNS VSI PHILIPS MEDICAL SYSTEMS 510(k) NO: K112652(SPECIAL) ATTN: MARY KRUITWAGEN PHONE NO : 978 659 2500 3000 MINUTEMAN RD. SE DECISION MADE: 11-OCT-11 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODIGY DIABETES MANAGEMENT SOFTWARE PRODIGY DIABETES CARE, LLC. 510(k) NO: K103115(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 12-OCT-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMCHEC PRESSURE MANAGEMET DEVICE FEMASYS INC. 510(k) NO: K110993(TRADITIONAL) ATTN: LISA PEACOCK PHONE NO : 770 500 3910 5000 RESEARCH COURT STE .100 SE DECISION MADE: 12-OCT-11 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SFC VERTEBRAL BODY REPLACEMENT KONIGSEE IMPLANTATE GMBH 510(k) NO: K110153(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 12-OCT-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM GE HEALTHCARE 510(k) NO: K111200(TRADITIONAL) ATTN: CAROL ALLOIAN PHONE NO : 847 244 8327 8200 WEST TOWER AVE SE DECISION MADE: 12-OCT-11 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA 510(k) NO: K111264(SPECIAL) ATTN: REGINA HOLMES PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 12-OCT-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER BEAM-MED LTD 510(k) NO: K110646(ABBREVIATED) ATTN: RITA KOREMBLUM PHONE NO : 972 392 36869 8 HALAPID STR. SE DECISION MADE: 12-OCT-11 PETACH TIKVA IS 49170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K111543(TRADITIONAL) ATTN: INDU LAKSHMAN PHONE NO : 408 207 4200 919 HERMOSA COURT SE DECISION MADE: 12-OCT-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BANTAM CATHETER (280MM BALLOON LENGTHS) CLEAR STREAM TECHNOLOGIES, LTD. 510(k) NO: K112335(TRADITIONAL) ATTN: FIONA NI MHULLAIN PHONE NO : 003 535 39237111 MOYNE UPPER, ENNISCORTHY SE DECISION MADE: 12-OCT-11 COUNTY WEXFORD EI 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP CORENTEC CO., LTD 510(k) NO: K112019(TRADITIONAL) ATTN: J.S. DANIEL PHONE NO : 82 234 455475 11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 12-OCT-11 SEOCHO GU, SEOUL KS 137-040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE BRONCUS TECHNOLOGIES, INC. 510(k) NO: K112051(SPECIAL) ATTN: MAHTAB FATEMI PHONE NO : 650 428 1600 1400N SHORELINE BLVD. BLDG. A, SUISE DECISION MADE: 12-OCT-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K112646(TRADITIONAL) ATTN: KYEONG-MI PARK PHONE NO : 822 219 41373 1003 DAECHI-DONG, GANGNAM-GU SE DECISION MADE: 12-OCT-11 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DISPOSABLE STIMULATING ELECTRODE NUVASIVE, INC. 510(k) NO: K111597(TRADITIONAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 13-OCT-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX VYGON CORP. 510(k) NO: K100163(TRADITIONAL) ATTN: CINDY VARUGHESE PHONE NO : 215 390 2002 103A PARK ROAD SE DECISION MADE: 13-OCT-11 MONTGOMERYVILLE PA 18936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT GRIFOLS 510(k) NO: K103757(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE ROAD SE DECISION MADE: 13-OCT-11 EAST STROUDSBURG PA 18301 510(k) STATEMENT DEVICE: MTF NEW BONE VOID FILLER MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K110003(TRADITIONAL) ATTN: NANCY JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 13-OCT-11 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVISIPORT STEALTH THERAPEUTICS, INCORPORATED510(k) NO: K110407(TRADITIONAL) ATTN: GARY J SYRING PHONE NO : 608 877 2635 800 LEVANGER LANE SE DECISION MADE: 13-OCT-11 STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS MATERIALISE N.V. 510(k) NO: K111492(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 32 16 396280 TECHNOLOGIELAAN 15 SE DECISION MADE: 13-OCT-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3B FLEX-LITE 3B PRODUCTS, LLC 510(k) NO: K103434(TRADITIONAL) ATTN: ALBERT ALEXANDER LUCIO PHONE NO : 863 676 5948 1142 N SCENIC HIGHWAY SE DECISION MADE: 13-OCT-11 LAKE WALES FL 33853 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULCUS BLUE PRODUITS DENTAIRES PIERRE ROLLAND 510(k) NO: K111978(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 856 745 1146 124 GAITHER DRIVE SUITE 140 SE DECISION MADE: 13-OCT-11 MT. LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) ALCON MANUFACTURING, LTD. 510(k) NO: K101774(TRADITIONAL) ATTN: CATHERINE GOBLE PHONE NO : 817 551 6816 6201 SOUTH FREEWAY SE DECISION MADE: 13-OCT-11 FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS ABBOT LABORATORIES 510(k) NO: K103627(TRADITIONAL) ATTN: JUDITH R WALLACH PHONE NO : 847 937 1132 100 ABBOTT PARK RD. DEPT. 9V6, AP6SE DECISION MADE: 14-OCT-11 ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE BIOMERIEUX, INC. 510(k) NO: K103752(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 14-OCT-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES TOTAL GLOVES SDN BHD 510(k) NO: K110250(TRADITIONAL) ATTN: OOI LOON SENG PHONE NO : 605 829 5512 KAMUNTING INDUSTRIAL ESTATE KAMUNTSE DECISION MADE: 14-OCT-11 TAIPING, PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSM SUBMERGED-R IMPLANT SYSTEM CSMIMPLANT 510(k) NO: K111120(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST. UNIT B SE DECISION MADE: 14-OCT-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARCUP DUAL MOBILITY SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K110135(TRADITIONAL) ATTN: THERESA LEISTER PHONE NO : 901 399 5899 1450 EAST BROOKS RD. SE DECISION MADE: 14-OCT-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX DIGOXIN ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K102346(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4452913 55 DIAMOND RD. SE DECISION MADE: 14-OCT-11 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT DEVICE: ADVIA CENTAUR VITAMIN D TOTAL ASSAY SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K110586(TRADITIONAL) ATTN: NEIL PARKER PHONE NO : 914 524 2477 511 BENEDICT AVENUE SE DECISION MADE: 14-OCT-11 TARRYTOWN NY 10509 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY SERIES VENTILATOR WITH OXIMETRY RESPIRONICS, INC. 510(k) NO: K111610(ABBREVIATED) ATTN: JOSEPH E OLSAVSKY PHONE NO : 724 387 7562 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 14-OCT-11 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC 510(k) NO: K111436(TRADITIONAL) ATTN: KENNETH B HERLAND PHONE NO : 651 429 7413 1290 HAMMOND RD. SE DECISION MADE: 14-OCT-11 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM WELLDOC, INC 510(k) NO: K112370(SPECIAL) ATTN: LAUREN BRONICH-HALL PHONE NO : 443 692 3100 1501 SAINT PAUL STREET SUITE 118 SE DECISION MADE: 14-OCT-11 BALTIMORE MD 21202 510(k) STATEMENT DEVICE: BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG SORIN GROUP ITALIA S.R.L. 510(k) NO: K112771(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 14-OCT-11 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLADIATOR HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K111910(TRADITIONAL) ATTN: MATT PAUL PHONE NO : 901 867 4350 5677 AIRLINE RD. SE DECISION MADE: 14-OCT-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK KURARAY MEDICAL INC. 510(k) NO: K111975(TRADITIONAL) ATTN: MICHIO TAKIGAWA PHONE NO : 81 367 011706 OTE CENTER BLD 7F, 1-1-3, OTEMACHISE DECISION MADE: 14-OCT-11 CHIYODA-KU, TOKYO JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL TRI-S BOND PLUS KURARAY AMERICA, INC. 510(k) NO: K111980(TRADITIONAL) ATTN: KIYOYUKI ARIKAWA PHONE NO : 212 986 2230 600 LEXINGTON AVE. 26TH FLOOR SE DECISION MADE: 14-OCT-11 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ELECTRODE SANIBEL SUPPLY 510(k) NO: K111737(SPECIAL) ATTN: ERIK NIELSEN PHONE NO : 456 371 3680 DREJERVAENGET 8 SE DECISION MADE: 14-OCT-11 ASSENS DA DK-5610 510(k) STATEMENT DEVICE: NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K112773(SPECIAL) ATTN: DAVID M GAISSER PHONE NO : 386 462 7661 13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 14-OCT-11 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K112694(SPECIAL) ATTN: SPENCER WALKER PHONE NO : 801 565 6103 12050 LONE PEAK PKWY SE DECISION MADE: 14-OCT-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE MEDRAD, INC. 510(k) NO: K112086(SPECIAL) ATTN: MIKE BURNSIDE PHONE NO : 763 717 1077 ONE MEDRAD DR. SE DECISION MADE: 14-OCT-11 INDIANOLA PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRIC EVOCERAM BULK FILL IVOCLAR VIVADENT, INC. 510(k) NO: K111958(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 14-OCT-11 AMHERST NY 14228 510(k) STATEMENT DEVICE: PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K103598(TRADITIONAL) ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 17-OCT-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA ALCON RESEARCH, LTD. 510(k) NO: K110951(TRADITIONAL) ATTN: MARTIN A KAUFMAN PHONE NO : 949 753 6250 15800 ALTON PARKWAY SE DECISION MADE: 17-OCT-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 5MP BARCO NV 510(k) NO: K111990(TRADITIONAL) ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 17-OCT-11 KORTRIJK BE 8500 510(k) STATEMENT DEVICE: SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING OMISA INC. (SEGASIST TECHNOLOGIES)510(k) NO: K111311(TRADITIONAL) ATTN: ALLISON MANNERS PHONE NO : 416 567 5176 1666 12TH LINE, RR #3 SE DECISION MADE: 17-OCT-11 LAKEFIELD, ONTARIO CA K0L 2H0 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8FR TURBO - TANDEM SYSTEM SPECTRANETICS CORP. 510(k) NO: K112032(TRADITIONAL) ATTN: SHELLEY WILCOX PHONE NO : 719 447 2414 9965 FEDERAL DR. SE DECISION MADE: 17-OCT-11 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K112710(SPECIAL) ATTN: GERHARD POLZER PHONE NO : 498 072 313705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 17-OCT-11 PFORZHEIM GM D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K112439(TRADITIONAL) ATTN: JYH-SHYAN LIN PHONE NO : 301 251 1092 419 WEST AVE. SE DECISION MADE: 17-OCT-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROGARD II CAREFUSION GERMANY 234 GMBH 510(k) NO: K111408(TRADITIONAL) ATTN: ELMAR NIEDERMEYER PHONE NO : 499 314 972361 LEIBNIZSTRASSE 7 SE DECISION MADE: 17-OCT-11 HOECHBERG, BAVARIA GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) GS MEDICAL CO., LTD. 510(k) NO: K111354(SPECIAL) ATTN: DONALD W GUTHNER PHONE NO : 646 460 2984 111 HILL ROAD PO BOX 395 SE DECISION MADE: 17-OCT-11 DOUGLASSVILLE PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K112156(TRADITIONAL) ATTN: JOCELYN RAPOSO PHONE NO : 508 828 3421 325 PARAMOUNT DRIVE SE DECISION MADE: 17-OCT-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ VEIN INFLATABLE TOURNIQUET DOMINION MEDICAL DEVICES, LLC 510(k) NO: K112874(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 17-OCT-11 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYSTON STRAIGHT SPACER SYSTEM BIOMET SPINE 510(k) NO: K112014(TRADITIONAL) ATTN: JULIE A RYAN PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 17-OCT-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIMAX TROCAR SYSTEM ACMEBIOTECHS CO., LTD 510(k) NO: K112358(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO. 45, MINSHENG RD. DANSHUI TOWN SE DECISION MADE: 17-OCT-11 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERYWAY LOW BACK PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K110716(TRADITIONAL) ATTN: ROBERT TU PHONE NO : 886 226 620038 3FL. NO.5 LANE 155, SEC 3 PEISHEN SE DECISION MADE: 18-OCT-11 TAIPEI HSIEN TW 222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABDOMINAL TOURNIQUET SYSTEM COMPRESSION WORKS LLC 510(k) NO: K112384(TRADITIONAL) ATTN: RUTH FORSTADT PHONE NO : 401 521 3294 15 SARGENT AVE SE DECISION MADE: 18-OCT-11 PROVIDENCE RI 02906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTLOC SPINAL FIXATION SYSTEM A-SPINE ASIA, CO., LTD 510(k) NO: K111883(TRADITIONAL) ATTN: FRANK HSU PHONE NO : 886 226 272977 11F., NO. 1, ALY. 30, LN. 358 RUIGSE DECISION MADE: 18-OCT-11 TAIPEI, NEIHU DISTRICT TW 11492510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APCLO PEDICLE SCREW SYSTEMS ATLAS SPINE INC. 510(k) NO: K112759(SPECIAL) ATTN: THOMAS G SMITH PHONE NO : 561 354 4318 1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 18-OCT-11 JUPITER FL 33458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K112586(TRADITIONAL) ATTN: KATIE COYLE PHONE NO : 410 316 4975 7 LOVETON CIRCLE MC 614 SE DECISION MADE: 18-OCT-11 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DASH HIP BRAINLAB, AG 510(k) NO: K110021(TRADITIONAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 18-OCT-11 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOACTIVE SEED LOCALIZATION NEEDLE BIOCOMPATIBLES INC. 510(k) NO: K111979(TRADITIONAL) ATTN: WAYNE RICHARDSON PHONE NO : 203 262 4194 115 Hurley Rd SE DECISION MADE: 18-OCT-11 OXFORD CT 06478 510(k) STATEMENT DEVICE: CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS BAXTER HEALTHCARE CORPORATION 510(k) NO: K112893(SPECIAL) ATTN: NANETTE HEDDEN PHONE NO : 847 270 4871 1620 WAUKEGAN RD. SE DECISION MADE: 18-OCT-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIA-CATH MILLAR INSTRUMENTS, INC. 510(k) NO: K112323(SPECIAL) ATTN: FATMA M ALI PHONE NO : 832 667 7000 6001-A GULF FREEWAY SE DECISION MADE: 18-OCT-11 HOUSTON TX 77023 5417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN ARK DIAGNOSTICS,INC 510(k) NO: K111904(TRADITIONAL) ATTN: KENNETH C KASPER PHONE NO : 408 747 0708 1190 BORDEAUX DRIVE SE DECISION MADE: 18-OCT-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC. 510(k) NO: K111909(TRADITIONAL) ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666 595 ANGLUM RD. SE DECISION MADE: 18-OCT-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS T4 CALCHECK 5 ROCHE DIAGNOSTICS CORPORATION 510(k) NO: K112528(TRADITIONAL) ATTN: MICHAEL LEUTHER PHONE NO : 317 521 3930 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 18-OCT-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-14 CONTROL WIRE GUIDEWIRE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K112745(SPECIAL) ATTN: SHANNON PETTIT PHONE NO : ONE SCIMED PLACE SE DECISION MADE: 18-OCT-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOFLASH(TM) INFRARED THERMOMETER VISIOMED GROUP SA 510(k) NO: K112929(TRADITIONAL) ATTN: ERIC SEBBAN PHONE NO : 331 406 70650 21, AVENUE VICTOR HUGE SE DECISION MADE: 18-OCT-11 PARIS FR 75116 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING 510(k) NO: K110345(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 19-OCT-11 HAIFA IS 10551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMT G-J TUBE APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K110804(TRADITIONAL) ATTN: JOSHUA D MEINKE PHONE NO : 440 717 4000 8000 KATHERINE BOULEVARD SE DECISION MADE: 19-OCT-11 BRECKSVILLE OH 44141 510(k) STATEMENT DEVICE: TBD LENSAR, INC. 510(k) NO: K112098(TRADITIONAL) ATTN: SHIRLEY MCGARVEY PHONE NO : 702 524 3701 2800 DISCOVERY DRIVE SUITE 100 SE DECISION MADE: 19-OCT-11 ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS IDEV TECHNOLOGIES, INC. 510(k) NO: K111766(TRADITIONAL) ATTN: DARENE GARNER PHONE NO : 281 525 2000 253 MEDICAL CENTER BLVD SE DECISION MADE: 19-OCT-11 WEBSTER TX 77598 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS ADVANCED MEDICAL PRODUCTS SDN BHD 510(k) NO: K110979(TRADITIONAL) ATTN: ZAHARI DARUS PHONE NO : 605 672 7559 LOT 8961 & 8964, BATU 19 JALAN BRUSE DECISION MADE: 20-OCT-11 AYER TAWAR MY 32400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER HEADLESS CANNULATED SCREWS TRILLIANT SURGICAL LTD 510(k) NO: K112737(SPECIAL) ATTN: J D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 20-OCT-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE NEXGEN MEDICAL SYSTEMS, INC. 510(k) NO: K110315(TRADITIONAL) ATTN: CRAIG PAGAN PHONE NO : 321 728 0126 1050 W. NASA BLVD. SUITE 136 SE DECISION MADE: 20-OCT-11 MELBOURNE FL 32901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRAFIX EXTERNAL FIXATION SYSTEM EXTRAORTHO INC 510(k) NO: K111155(TRADITIONAL) ATTN: MARCOS VELEZ-DURAN PHONE NO : 703 562 9800 901 KING ST SUITE 200 SE DECISION MADE: 20-OCT-11 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD GENEOHM VANR ASSAY BD DIAGNOSTICS SCIENCE 510(k) NO: K102416(TRADITIONAL) ATTN: RAYMOND BOULE PHONE NO : 410 316 4542 7 LOVETON CIRCLE MAIL CODE 614 SE DECISION MADE: 20-OCT-11 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART TOUCH UVTHERAPY MULTIPLE MACHINE DAAVLIN DISTRIBUTING CO. 510(k) NO: K110912(TRADITIONAL) ATTN: MICHELE THIEL PHONE NO : 419 636 6304 205 WEST BEMENT ST. SE DECISION MADE: 20-OCT-11 BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESTREAM PACS CARESTREAM HEALTH, INC. 510(k) NO: K110919(TRADITIONAL) ATTN: LINDA STEWART PHONE NO : 972 517 1481 150 VERONA STREET SE DECISION MADE: 20-OCT-11 ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGIVIEW 250 KUB TECHNOLOGIES, INC 510(k) NO: K103348(TRADITIONAL) ATTN: VIKRAM BUTANI PHONE NO : 203 364 8544 270 ROWE AVENUE SUITE E SE DECISION MADE: 20-OCT-11 MILFORD CT 06460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES XRL SYNTHES SPINE CO.LP 510(k) NO: K103320(TRADITIONAL) ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LANE EAST SE DECISION MADE: 20-OCT-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 LINDE HEALTHCARE AB 510(k) NO: K101286(TRADITIONAL) ATTN: ANDERS PALM PHONE NO : 467 039 08875 AGAVAGEN 54 SE DECISION MADE: 20-OCT-11 LIDINGO SW SE 18181 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUCON-F FROZEN UNASSAYED NORMAL CONTROL PLASMA, VISUCON-F FROZEN UNASSAYED ABNORMAL CONTROL 1 PLASMA AFFINITY BIOLOGICALS INC. 510(k) NO: K110432(TRADITIONAL) ATTN: DENISE FOULON PHONE NO : 905 304 9896 1395 SANDHILL DRIVE SE DECISION MADE: 20-OCT-11 ANCASTER, ONTARIO CA L9G 4V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADRA BLOC TENS PLUS GRADIENT TECHNOLOGIES, LLC 510(k) NO: K102278(TRADITIONAL) ATTN: JOHN TOWNSEND PHONE NO : 901 767 2384 6070 POPLAR AVENUE SIXTH FLOOR SE DECISION MADE: 20-OCT-11 MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANISHPOINT BLOOD COLLECTION SET RETRACTABLE TECHNOLOGIES, INC. 510(k) NO: K112512(TRADITIONAL) ATTN: RHONDA WELLS PHONE NO : 972 294 1010 511 LOBO LN. SE DECISION MADE: 20-OCT-11 LITTLE ELM TX 75068 0009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL KIMBERLY-CLARK 510(k) NO: K111402(ABBREVIATED) ATTN: ANN WATERHOUSE, RAC PHONE NO : 678 352 6719 1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 20-OCT-11 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALERKAN SPIROMETRY FILTER ALERKAN LTD 510(k) NO: K111587(TRADITIONAL) ATTN: GLEN FEYE PHONE NO : 619 517 1762 1340 WEST PENNSYLVANIA AVE. SE DECISION MADE: 20-OCT-11 SAN DIEGO CA 92013 510(k) STATEMENT DEVICE: THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE REGULATORY SPECIALISTS, INC. 510(k) NO: K112468(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 3722 AVE SAUSALITO SE DECISION MADE: 20-OCT-11 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPSONIX(R) SYSTEM MODEL 2 MEDICIS TECHNOLOGIES CORPORATION 510(k) NO: K112626(SPECIAL) ATTN: MICHAEL A HOFFMAN PHONE NO : 425 420 2135 11818 NORTH CREEK PARKWAY N. SE DECISION MADE: 20-OCT-11 BOTHELL WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASTLYTE NA/K/CA/PH MEDICA CORP. 510(k) NO: K112788(SPECIAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 20-OCT-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: NEUROLAC(R) NERVE GUIDE POLYGANICS BV 510(k) NO: K112267(SPECIAL) ATTN: BETTY IJMKER PHONE NO : 31 50 5886598 ROZENBURGLAAN 15A SE DECISION MADE: 20-OCT-11 GRONINGEN NL 9727-DL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE OSTAR MEDITECH CORP. 510(k) NO: K112269(TRADITIONAL) ATTN: STEVEN CHANG PHONE NO : 886 229 182390 5F, NO. 46-4, MIN-CHIUAN RD. SHINGSE DECISION MADE: 20-OCT-11 NEW TAIPEI CITY TW 231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELTEX MEDICAL CARDIOQ EDM DELTEX MEDICAL LIMITED 510(k) NO: K111542(TRADITIONAL) ATTN: NEIL R ARMSTRONG PHONE NO : 44 176 3222505 BIOPARK, BROADWATER ROAD WELWYN GASE DECISION MADE: 20-OCT-11 HERTSFORDSHIRE UK AL7 3AX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM CURVE DENTAL, INC. 510(k) NO: K112974(TRADITIONAL) ATTN: GEORGE STANTCHEV PHONE NO : 888 910 4376 424 W. 800 N. SUITE 202 SE DECISION MADE: 20-OCT-11 OREM UT 84057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K111772(TRADITIONAL) ATTN: CHO SOW FONG PHONE NO : 603 33 927616 LOT 6129,JALAN HAJI ABDUL MANAN, OSE DECISION MADE: 20-OCT-11 KLANG, SELANGOR D.E. MY 41050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC 510(k) NO: K112283(TRADITIONAL) ATTN: LAVENIA FORD PHONE NO : 847 887 3323 1430 WAUKEGAAN ROAD SE DECISION MADE: 20-OCT-11 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUANTA FLASH (TM) DGP SCREEN INOVA DIAGNOSTICS, INC. 510(k) NO: K111414(TRADITIONAL) ATTN: RUFUS BURLINGAME PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 20-OCT-11 SAN DIEGO CA 92131 1638 510(k) STATEMENT DEVICE: X-TRA BASE VOCO GMBH 510(k) NO: K112374(TRADITIONAL) ATTN: T. GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 20-OCT-11 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: SAPIENS TIP CONFIRMATION SYSTEM C.R. BARD, INC. 510(k) NO: K112744(SPECIAL) ATTN: HENRY BOLAND PHONE NO : 801 595 0700 605 NORTH 5600 WEST SE DECISION MADE: 20-OCT-11 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC 510(k) NO: K112211(TRADITIONAL) ATTN: LAVENIA FORD PHONE NO : 847 887 3323 1430 WAUKEGAAN ROAD SE DECISION MADE: 20-OCT-11 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VIZION DR VIZTEK LLC 510(k) NO: K112661(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT. SE DECISION MADE: 20-OCT-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VRESELECT CULTURE MEDIUM BIO-RAD 510(k) NO: K103684(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978 927 3808 180 CABOT STREET SE DECISION MADE: 21-OCT-11 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSPIRE DEBRIDER SYSTEM SPINE VIEW, INC. 510(k) NO: K110992(TRADITIONAL) ATTN: MBITHI MUTHINI PHONE NO : 510 743 5090 48810 KATO ROAD SUITE 100E SE DECISION MADE: 21-OCT-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOGLOVE ES WITH ECG ANALYSIS COMMWELL LTD. 510(k) NO: K103791(TRADITIONAL) ATTN: IRVING LEVY PHONE NO : 972 976 68094 RECHOV YAD HARUTZIM 4 SE DECISION MADE: 21-OCT-11 KFAR SABA IS 44641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM INTROMEDIC CO., LTD 510(k) NO: K111030(TRADITIONAL) ATTN: JINYOUNG LEE PHONE NO : SUITE 1104 E&C VENTURE DREAM TOWERSE DECISION MADE: 21-OCT-11 GURO-GU , SEOUL KS 152719 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIFECARE ARM & LEG PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K112415(TRADITIONAL) ATTN: ROBERT TU PHONE NO : 886 226 620038 3FL. NO.5 LANE 155, SEC 3 PEISHEN SE DECISION MADE: 21-OCT-11 TAIPEI HSIEN TW 222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIOSLIMON IMPLANT SYSTEM DIO CORPORATION 510(k) NO: K112746(SPECIAL) ATTN: TIMOTHY LEE PHONE NO : 213 365 2875 3540 WILSHIRE BLVD. SUITE 1104 SE DECISION MADE: 21-OCT-11 LOS ANGELES CA 90010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE 510(k) NO: K111639(SPECIAL) ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 21-OCT-11 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE W AND R INVESTMENTS DBA LASER ENGI510(k) NO: K112166(TRADITIONAL) ATTN: ROBERT I RUDKO PHONE NO : 508 520 2552 113 CEDAR STREET SE DECISION MADE: 21-OCT-11 MILFORD MA 01757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER STRYKER SUSTAINABILITY SOLUTIONS 510(k) NO: K112292(TRADITIONAL) ATTN: RAMONA KULIK PHONE NO : 480 763 2952 5307 Great Oak Dr SE DECISION MADE: 21-OCT-11 LAKELAND FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER ST. JUDE MEDICAL SYSTEMS AB 510(k) NO: K111854(TRADITIONAL) ATTN: MIKAEL SJOLANDER PHONE NO : 46 181 61000 PALMBLADSGATAN 10 SE DECISION MADE: 21-OCT-11 UPPSALA SW SE-751 35 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K112473(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 301 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 21-OCT-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) INOVISE MEDICAL, INC. 510(k) NO: K110569(TRADITIONAL) ATTN: EARL ANDERSON PHONE NO : 503 431 3800 8770 SW NIMBUS AVENUE SUITE D SE DECISION MADE: 24-OCT-11 BEAVERTON OR 97008 7196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAMEWALKER QUANTUM MEDICAL CONCEPTS, LLC. 510(k) NO: K111993(TRADITIONAL) ATTN: ALICIA BACH PHONE NO : 503 233 3984 3518 SE 21ST AVE. SE DECISION MADE: 24-OCT-11 PORTLAND OR 97202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE L & K BIOMED CO., LTD 510(k) NO: K110783(TRADITIONAL) ATTN: HEE KYEONG JOO PHONE NO : 822 262 41471 ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 24-OCT-11 SEOUL KS 153803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES MEDISCOPE MANUFACTURING, INC. 510(k) NO: K102387(TRADITIONAL) ATTN: DIANE SUDDUTH MS, DVM, MPHPHONE NO : 561 305 5075 8282 SHADOW WOOD BLVD SE DECISION MADE: 24-OCT-11 POMPANO BEACH FL 33069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOKNIFE SYSTEM ANGIODYNAMICS, INC. 510(k) NO: K102329(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 24-OCT-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K103513(TRADITIONAL) ATTN: JULIE GLENDRANGE PHONE NO : 310 533 9966 386 BEECH AVENUE UNIT B6 SE DECISION MADE: 24-OCT-11 TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFIA ANALYZER AND INFLUENZA A+B FIA QUIDEL CORP. 510(k) NO: K112177(TRADITIONAL) ATTN: JOHN D TAMERIUS PHONE NO : 858 552 7908 10165 MCKELLAR CT. SE DECISION MADE: 24-OCT-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K112803(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 24-OCT-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINGEATER V2 JMS NORTH AMERICA CORPORATION 510(k) NO: K111948(SPECIAL) ATTN: E J SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE. SE DECISION MADE: 24-OCT-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. BARD, INC. 510(k) NO: K112497(SPECIAL) ATTN: JONI CREAL PHONE NO : 480 638 2906 1625 WEST 3RD ST. SE DECISION MADE: 24-OCT-11 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFIRM (TM) VCF SYSTEM ALGEA THERAPIES 510(k) NO: K110998(TRADITIONAL) ATTN: KELLY J BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVENUE SE DECISION MADE: 25-OCT-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM RESPIRONICS RESPIRATORY DRUG DELIV510(k) NO: K102454(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 25-OCT-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K111825(TRADITIONAL) ATTN: FRANK GIANELLI PHONE NO : 203 492 5352 60 Middletown Ave SE DECISION MADE: 25-OCT-11 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF SYNOVIS ORTHOPEDIC AND WOUNDCARE, 510(k) NO: K112786(SPECIAL) ATTN: AMY BOUCLY PHONE NO : 949 502 3240 6 JENNER SUITE 150 SE DECISION MADE: 25-OCT-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARGER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC 510(k) NO: K112701(SPECIAL) ATTN: GLENN JACQUES PHONE NO : 763 494 1152 ONE SCIMED PLACE SE DECISION MADE: 25-OCT-11 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVIVE INTERMEDIATE CATHETER (REVIVE IC) CODMAN & SHURTLEFF, INC. 510(k) NO: K112828(SPECIAL) ATTN: CATHERINE KILSHAW PHONE NO : 508 828 3312 325 PARAMOUNT DR. SE DECISION MADE: 25-OCT-11 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS ELEVATE PC AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K112842(SPECIAL) ATTN: MATTHEW D STEPANEK PHONE NO : 952 930 6000 10700 BREN RD., WEST SE DECISION MADE: 25-OCT-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALIX KNOTLESS(TM) ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K112249(TRADITIONAL) ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 25-OCT-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKAFFOLD CIS SKELETAL KINETICS, LLC 510(k) NO: K111538(TRADITIONAL) ATTN: CHRISTINE KUO PHONE NO : 408 350 5842 10201 BUBB RD. SE DECISION MADE: 25-OCT-11 CUPERTINO CA 95014 4167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VUSION(R) OS ORTHO DEVELOPMENT 510(k) NO: K111965(TRADITIONAL) ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 25-OCT-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS BAUSCH & LOMB, INC. 510(k) NO: K112192(SPECIAL) ATTN: TRICIA GARRETT PHONE NO : 585 338 6706 1400 NORTH GOODMAN ST. SE DECISION MADE: 25-OCT-11 ROCHESTER NY 14609 3547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM JOHNSON & JOHNSON 510(k) NO: K110551(SPECIAL) ATTN: FRANK JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DR. SE DECISION MADE: 26-OCT-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH DIAGNOSTICA STAGO, INC. 510(k) NO: K111822(TRADITIONAL) ATTN: CARLO D'ALESSANDRO PHONE NO : 39 065 782665 PIAZZA ALBANIA, 10 SE DECISION MADE: 26-OCT-11 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM THOMPSON MIS INC 510(k) NO: K111512(TRADITIONAL) ATTN: FRANK SULLIVAN PHONE NO : 603 912 5306 45 STILES RD SUITE 210 SE DECISION MADE: 26-OCT-11 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-ANALYTE DETECTION SYSTEMS BIO-RAD LABORATORIES 510(k) NO: K112810(SPECIAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 26-OCT-11 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K111621(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 26-OCT-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STREPTOCOCCUS PENICILLIN BIOMERIEUX, INC. 510(k) NO: K112000(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 26-OCT-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NCB PERIPROSTHETIC FEMUR POLYASIAL LOCKING PLATE SYSTEM ZIMMER, INC. 510(k) NO: K112174(SPECIAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944 P.O. BOX 708 SE DECISION MADE: 26-OCT-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARSPLINT ES ASTRON DENTAL CORPORATION 510(k) NO: K111828(TRADITIONAL) ATTN: DOUGLAS S MULLER PHONE NO : 847 726 8787 815 OAKWOOD RD. UNIT G SE DECISION MADE: 26-OCT-11 LAKE ZURICH IL 60047 510(k) STATEMENT DEVICE: US-101L, US-103S ITO CO., LTD. 510(k) NO: K112520(TRADITIONAL) ATTN: HARUHISA OKADA PHONE NO : 813 399 48996 3-3-3 TOYOTAMA-MINAMI NERIMA-KU SE DECISION MADE: 26-OCT-11 TOKYO JA 176-0014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IPC POWEREASE SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K111520(TRADITIONAL) ATTN: RISHI SINHA PHONE NO : 817 788 6685 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 26-OCT-11 JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES STERNAL FIXATION SYSTEM SYNTHES INC 510(k) NO: K112689(SPECIAL) ATTN: ELIZABETH KIERZEK PHONE NO : 610 719 6565 1301 GOSHEN PARKWAY SE DECISION MADE: 26-OCT-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC 510(k) NO: K111010(TRADITIONAL) ATTN: BRENDA JOHNSON PHONE NO : 763 398 7238 3033 CAMPUS DRIVE SE DECISION MADE: 27-OCT-11 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSRAM ITOS OSRAM SYLVANIA, INC. 510(k) NO: K110326(TRADITIONAL) ATTN: MARIE A SCHROEDER PHONE NO : 301 272 3286 1801 ROCKVILLE PIKE SUITE 300 SE DECISION MADE: 27-OCT-11 ROCKVILLE MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL RESCUENETLINK ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K111296(TRADITIONAL) ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 27-OCT-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP- MEITHKE SHUNT SYSTEM AESCULAP, INC. 510(k) NO: K110206(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 27-OCT-11 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4MP COLOR LCD MONITOR, RADIFORCERX430 EIZO NANAO CORPORATION 510(k) NO: K112466(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, HAKUSAN SE DECISION MADE: 27-OCT-11 ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D 600 AGFA HEALTHCARE N.V. 510(k) NO: K112670(TRADITIONAL) ATTN: PHIL CUSCUNA PHONE NO : 416 240 7317 10 S ACADEMY STREET SE DECISION MADE: 27-OCT-11 GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) TOTOKU ELECTRIC CO., LTD 510(k) NO: K112604(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 812 582 46611 300 OYA SE DECISION MADE: 27-OCT-11 UEDA, NAGANO JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC 510(k) NO: K112849(SPECIAL) ATTN: RACHEL KENNEDY PHONE NO : 952 224 4000 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 27-OCT-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REHASTIM 2, REHAMOVE 2 HASOMED GMBH 510(k) NO: K112844(SPECIAL) ATTN: MATTHIAS WEBER PHONE NO : 493 916 230112 PAUL-ECKE-STRASSE 1 SE DECISION MADE: 27-OCT-11 MAGDEBURG GM 39114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L GIOTTO USA, LLC 510(k) NO: K111434(TRADITIONAL) ATTN: PATRICK MOONEY PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 27-OCT-11 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIZIA ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC. 510(k) NO: K111796(TRADITIONAL) ATTN: ELSA LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE RD. SE DECISION MADE: 27-OCT-11 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VSI GUIDEWIRE VASCULAR SOLUTIONS, INC. 510(k) NO: K112631(TRADITIONAL) ATTN: MELINDA SWANSON PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 27-OCT-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCATRON AND / OR MULTIPLE BRAND ALCATRON GLOVES FACTORY 510(k) NO: K112222(TRADITIONAL) ATTN: SHUQIN GAO PHONE NO : 86 536 2197155 NO. 12-1, XING'AN RD EAST LINQU, WSE DECISION MADE: 27-OCT-11 SHANDONG CH 262600 510(k) STATEMENT DEVICE: JMS APHERESIS NEEDLE SET "WINGEATER(R)" V2 JMS NORTH AMERICA CORPORATION 510(k) NO: K112178(SPECIAL) ATTN: E.J. SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE. SE DECISION MADE: 27-OCT-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112529(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 27-OCT-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETAL DOPPLER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K112911(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 27-OCT-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID MEDTRONIC, INC. 510(k) NO: K112917(SPECIAL) ATTN: DEBORAH KIDDER PHONE NO : 763 526 3561 8200 CORAL SEA STREET MS MVS11 SE DECISION MADE: 27-OCT-11 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS NORFOLK MEDICAL PRODUCTS, INC. 510(k) NO: K112713(SPECIAL) ATTN: MICHAEL DALTON PHONE NO : 847 674 7075 7350 NORTH RIDGEWAY SE DECISION MADE: 27-OCT-11 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC 510(k) NO: K111723(TRADITIONAL) ATTN: BRENDA JOHNSON PHONE NO : 763 398 7000 3033 CAMPUS DRIVE SE DECISION MADE: 27-OCT-11 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM MAHE MEDICAL GMBH 510(k) NO: K110655(ABBREVIATED) ATTN: ANDREA PECSI PHONE NO : 497 462 924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 27-OCT-11 TUTTLINGEN, BW GR 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION I-SENS, INC. 510(k) NO: K103278(SPECIAL) ATTN: HYUN JOON OH PHONE NO : 82 291 66191 465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 28-OCT-11 SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUOCENTRIC REVERSED ASTON MEDICAL 510(k) NO: K103251(TRADITIONAL) ATTN: CATHERINE GLOSTER PHONE NO : 805 679 1258 577 NORTH HOPE AVE SE DECISION MADE: 28-OCT-11 SANTA BARBARA CA 93110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY 510(k) NO: K112277(TRADITIONAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 28-OCT-11 SAN DIEGO CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI MASSEUSE MJ SPECIALTY RETAIL 510(k) NO: K110057(TRADITIONAL) ATTN: CHARLES MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 28-OCT-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS NIHON KOHDEN CORP. 510(k) NO: K110594(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 28-OCT-11 FOOTHILL RANCH CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS 510(k) NO: K111693(TRADITIONAL) ATTN: TAMARA YOUNT PHONE NO : 206 664 5000 2301 5TH AVENUE, SUITE 200 SE DECISION MADE: 28-OCT-11 SEATTLE WA 98121 1825 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUMO ACCESS AND TISSUE RESECTION SYSTEM APOLLO ENDOSURGERY, INC. 510(k) NO: K103155(TRADITIONAL) ATTN: GREG MATHISON PHONE NO : 512 328 9990 7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 28-OCT-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS NEUROVIRTUAL USA, INC. 510(k) NO: K112107(TRADITIONAL) ATTN: EDUARDO FARIA PHONE NO : 786 693 8200 2315 NW 107TH AVE SUITE #1M27 SE DECISION MADE: 28-OCT-11 DORAL FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYRINGES AND NEEDLES JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K113091(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 28-OCT-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHX=CHX PLUS INTER-MED, INC. 510(k) NO: K112250(TRADITIONAL) ATTN: JOHN BAETEN PHONE NO : 262 636 9755 2200 NORTHWESTERN AVE. SE DECISION MADE: 28-OCT-11 RACINE WI 53404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS NOBEL BIOCARE AB 510(k) NO: K112259(SPECIAL) ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 28-OCT-11 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFRELINER TOUGH S TOKUYAMA DENTAL CORPORATION 510(k) NO: K112445(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202 783 5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 28-OCT-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL VOLAR RADIUS PLATING SYSTEMS MEDOS INTERNATIONAL SARL 510(k) NO: K112345(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 31-OCT-11 WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K111683(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 JN PEASE PLACE SE DECISION MADE: 31-OCT-11 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLO-SURPLUS P.A.D. SCION CARDIO-VASCULAR, INC. 510(k) NO: K112961(SPECIAL) ATTN: CRAIG PAGAN PHONE NO : 321 728 0125 1050 W NASA BLVD # 136 SE DECISION MADE: 31-OCT-11 MELBOURNE FL 32901 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 17
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