Medical Devices
-
July 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2011 DEVICE: SP DYNAMICS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A FOTONA D.D. 510(k) NO: K101306(TRADITIONAL) ATTN: STOJAN TROST PHONE NO : 386 150 09100 STEGNE 7, SE DECISION MADE: 01-JUL-11 LJUBLJANA SI 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL-LIFE OTC EMS SYSTEM WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K102786(TRADITIONAL) ATTN: JENNY HSIEH PHONE NO : 886 229 282112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 01-JUL-11 YUNGHE CITY, TAIPEI COUNTY TW 2510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS 510(k) NO: K111118(SPECIAL) ATTN: MONA INMAN PHONE NO : 952 930 6204 10700 BREN RD WEST SE DECISION MADE: 01-JUL-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA POCT MANAGMENT SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K111029(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 01-JUL-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN ZIMMER, INC. 510(k) NO: K110940(TRADITIONAL) ATTN: CAROL VIERLING PHONE NO : 574 372 4964 P.O. BOX 708 SE DECISION MADE: 01-JUL-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT MARQUIS FLOW SWITCH MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K110643(TRADITIONAL) ATTN: MARK MULLANEY PHONE NO : 353 917 03761 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 01-JUL-11 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. 510(k) NO: K110682(TRADITIONAL) ATTN: TANIA LUPU PHONE NO : 201 313 1999 19 EMPIRE BLVD SE DECISION MADE: 01-JUL-11 SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN LOW PROFILE BONE SCREW SMITH & NEPHEW, INC. 510(k) NO: K111025(TRADITIONAL) ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 01-JUL-11 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOUT TRACKING SYSTEM ROBIN MEDICAL, INC. 510(k) NO: K111226(SPECIAL) ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHADOWBROOK DRIVE SE DECISION MADE: 01-JUL-11 HUDSON NH 03051 510(k) STATEMENT DEVICE: ATLANTEAN TRIGGER NEBULIZER ATLANTEAN CORPORATION 510(k) NO: K102719(TRADITIONAL) ATTN: TOM SHANKS PHONE NO : 951 506 2674 29201 VIA NORTE SE DECISION MADE: 01-JUL-11 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLANT 2011 MATERIALISE DENTAL NV 510(k) NO: K110300(SPECIAL) ATTN: PETER VANDEPUT PHONE NO : 32 16 39 60 39 TECHNOLOGIELAAN 15 SE DECISION MADE: 01-JUL-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN SIESTA MEDICAL, INC. 510(k) NO: K111179(SPECIAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 101 CHURCH STREET SUITE 3 SE DECISION MADE: 01-JUL-11 LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K103776(TRADITIONAL) ATTN: LUBNA SYED PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SUITE 900 SE DECISION MADE: 01-JUL-11 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 PRECISION MEDICAL, INC. 510(k) NO: K103563(TRADITIONAL) ATTN: JAMES PARKER PHONE NO : 610 262 6090 300 HELD DR. SE DECISION MADE: 01-JUL-11 NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 HIP SYSTEM UNITED ORTHOPEDIC CORP. 510(k) NO: K111546(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351 NO 57 PARK AVE. 2 SCIENCE PARK SE DECISION MADE: 01-JUL-11 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K102648(TRADITIONAL) ATTN: LYNN FU PHONE NO : 867 558 6090992 BLDG 11 LISHAN INDUSTRIAL PARK XINSE DECISION MADE: 01-JUL-11 SHENZHEN, GUANGDONG CH 518052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEX CO2 / ER:YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110897(TRADITIONAL) ATTN: MARK ROHRER PHONE NO : 205 290 8251 105 CITATION COURT SE DECISION MADE: 01-JUL-11 HOMEWOOD AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC 510(k) NO: K111596(SPECIAL) ATTN: ANDREW RODENHOUSE PHONE NO : 616 706 3903 4670 FULTON STREET E SE DECISION MADE: 05-JUL-11 ADA MI 49301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS MONITORING SYSTEM CAREFUSION 303, INC. 510(k) NO: K110809(TRADITIONAL) ATTN: SIMON PEARMAIN PHONE NO : 440 123 5438950 115 MITON PARK BUILDING 3 SE DECISION MADE: 05-JUL-11 ABINGDON,OXON UK OX 14 4RZ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT MAINE STANDARDS COMPANY, LLC 510(k) NO: K110880(TRADITIONAL) ATTN: HOLLY CRESSMAN PHONE NO : 207 892 1300 765 ROOSEVELT TRAIL SE DECISION MADE: 05-JUL-11 WINDHAM ME 04062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K110925(TRADITIONAL) ATTN: DAVID M GAISSER PHONE NO : 386 462 7661 13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 05-JUL-11 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SV DBS VRAIN ARRAY MIDWEST RF, LLC 510(k) NO: K111259(TRADITIONAL) ATTN: HELMUT KEIDI PHONE NO : 262 367 6925 P.O. BOX 348 1015 WALNUT RIDGE DRISE DECISION MADE: 05-JUL-11 HARTLAND WI 53029 510(k) STATEMENT DEVICE: ASCOM MOBILE MONITORING GATEWAY (MMG) ASCOM (SWEDEN) AB 510(k) NO: K111215(TRADITIONAL) ATTN: TANIA OTTEBRINK PHONE NO : 46 31 559300 GRIMBODALEN 2, P.O. BOX 8783 SE DECISION MADE: 05-JUL-11 GOTEBORG SW SE-402-76 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K092688(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 2 66258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 06-JUL-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) TRUE GLOVE FACTORY 510(k) NO: K111012(TRADITIONAL) ATTN: FRANK YANG PHONE NO : 865 363 775588 NO.6-1 XINGAN ROAD EAST, LINQU SE DECISION MADE: 06-JUL-11 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: PARKER 500 ARJOHUNTLEIGH INC 510(k) NO: K110994(ABBREVIATED) ATTN: BRENDA AMMONETTE PHONE NO : 630 785 4885 2349 WEST LAKE STREET SUITE 250 SE DECISION MADE: 06-JUL-11 ADDISON IL 60101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIGURE 8 STERNOTOMY CLOSURE DEVICE FIGURE 8 SURGICAL, INCORPORATED 510(k) NO: K110541(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE, SUITE 21SE DECISION MADE: 06-JUL-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVLOK FENESTRATED SCREW SYSTEM GLOBE MEDICAL, INC. 510(k) NO: K110280(SPECIAL) ATTN: KELLY J BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 06-JUL-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATEAU SPACER SYSTEM LIFE SPINE 510(k) NO: K111569(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 06-JUL-11 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM GRAHAM MEDICAL TECHNOLOGIES, L.L.C510(k) NO: K111326(TRADITIONAL) ATTN: JULIE POWELL PHONE NO : 512 327 9997 611 WEST 5TH STREET, THIRD FLOOR SE DECISION MADE: 06-JUL-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPER SYSTEMS JOHNSON & JOHNSON 510(k) NO: K111571(SPECIAL) ATTN: DAPHNEY GERMAIN-KOLAWOLE PHONE NO : 508 880 8395 325 PARAMOUNT DR. SE DECISION MADE: 06-JUL-11 RAYNHAM MA 02767 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K111619(SPECIAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 06-JUL-11 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K101381(TRADITIONAL) ATTN: DONNA MILLISKY PHONE NO : 609 936 2454 311 ENTERPRISE DR. SE DECISION MADE: 07-JUL-11 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. 510(k) NO: K110696(TRADITIONAL) ATTN: EDWARD SINCLAIR PHONE NO : 408 514 2200 655 RIVER OAKS PKWY SE DECISION MADE: 07-JUL-11 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K103714(TRADITIONAL) ATTN: MARY L ARMSTRONG PHONE NO : 303 223 4336 555 ZANG STREET, SUITE 100 SE DECISION MADE: 07-JUL-11 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURELIFT PROLAPSE SYSTEM NEOMEDIC INTERNATIONAL 510(k) NO: K102815(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 952 835 4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 07-JUL-11 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM FORA CARE INC. 510(k) NO: K110044(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F, 5F, 6F, NO.127, WUGONG 2ND RD.SE DECISION MADE: 07-JUL-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. 510(k) NO: K111194(SPECIAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 2511 FOX RIVER CIRCLE SE DECISION MADE: 07-JUL-11 WAUKESHA WI 53189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERO MEDICAL PREDICTIVE SCIENCE CORP. 510(k) NO: K111601(SPECIAL) ATTN: WILL KING PHONE NO : 434 220 0714 2246 IVY RD., SUITE 17 SE DECISION MADE: 08-JUL-11 CHARLOTTESVILLE VA 22903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K111150(TRADITIONAL) ATTN: JONATHAN RUTIGLIANO PHONE NO : 303 660 4201 74 INVERNESS DRIVE EAST SE DECISION MADE: 08-JUL-11 ENGLEWOOD CO 80112 510(k) STATEMENT DEVICE: PAINFUSOR CATHETER PLAN 1 HEALTH, S.R.L. 510(k) NO: K111031(TRADITIONAL) ATTN: SIGI CARON PHONE NO : 310 377 3069 2400 VIA CARILLO SE DECISION MADE: 08-JUL-11 PALOS VERDES ESTATES CA 90274 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL VARIA 3 ROCHE DIAGNOSTICS 510(k) NO: K111506(TRADITIONAL) ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE ROAD P.O. BOX 50410 SE DECISION MADE: 08-JUL-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHA2020 ANNIDIS HEALTH SYSTEMS CORP. 510(k) NO: K111531(TRADITIONAL) ATTN: MICHAEL MCDONNELL PHONE NO : 613 596 1800 2650 QUEENSVIEW DRIVE SUITE 245 SE DECISION MADE: 08-JUL-11 OTTAWA, ONTARIO CA K2B 8H6 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDIOSTAR NEXT ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K111851(SPECIAL) ATTN: ANTJE KATZER PHONE NO : 493 641 7700309 BRUESSELER STR. 10 SE DECISION MADE: 08-JUL-11 JENA GM 07747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL FACTOR VIII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. 510(k) NO: K110237(TRADITIONAL) ATTN: JACQUELINE EMERY PHONE NO : 781 861 4350 180 HARTWELL ROAD SE DECISION MADE: 08-JUL-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DP-6900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K111435(SPECIAL) ATTN: SUSAN D GOLDSTEIN PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 08-JUL-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT ARAGON SURGICAL INC. 510(k) NO: K110824(TRADITIONAL) ATTN: ALAN CURTIS PHONE NO : 925 209 7174 3617 SCOTT STREET SE DECISION MADE: 11-JUL-11 SAN FRANCISCO CA 94123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 CARTICEPT MEDICAL INC 510(k) NO: K101194(TRADITIONAL) ATTN: TANYA EBERLE PHONE NO : 770 754 3814 6120 WINDWARD PARKWAY SUITE 220 SE DECISION MADE: 11-JUL-11 ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG YINGHONG MEDICAL PRODUCTS510(k) NO: K110981(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 12-JUL-11 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYFIT SILKGEL NASAL MASK WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K110884(SPECIAL) ATTN: RALF EGENOLF PHONE NO : 49 405 4702370 KRONSAALSWEG 40 SE DECISION MADE: 12-JUL-11 HAMBURG GM 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO FIXATION SYSTEM SYNOVIS ORTHOPEDIC & WOUNDCARE 510(k) NO: K110538(TRADITIONAL) ATTN: AMY BOUCLY PHONE NO : 949 502 3240 6 Jenner, Suite 150 SE DECISION MADE: 12-JUL-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERI-DENT, STERI-SURE CPAC, INC. 510(k) NO: K094026(TRADITIONAL) ATTN: JEFFREY CRANE PHONE NO : 585 382 3223 2364 LEICESTER RD. P.O. BOX 175 SE DECISION MADE: 12-JUL-11 LEICESTER NY 14481 0175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT MEDICA CORPORATION 510(k) NO: K111036(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 12-JUL-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: TITAN TI SUTURE ANCHOR SYSTEM ARTHROCARE CORP. 510(k) NO: K111397(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 12-JUL-11 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSORB RESORBABLE PINS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K111077(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-JUL-11 WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K101997(TRADITIONAL) ATTN: JOHN MCINTYRE PHONE NO : 949 837 3600 13844 ALTON PARKWAY SUITE 130 SE DECISION MADE: 12-JUL-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOLOGIX AFX INTRODUCER SYSTEM ENDOLOGIX, INC. 510(k) NO: K111747(SPECIAL) ATTN: JANET M FAULS PHONE NO : 949 595 7203 11 STUDEBAKER SE DECISION MADE: 12-JUL-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES SMITH & NEPHEW, INC. 510(k) NO: K110670(TRADITIONAL) ATTN: DAVID HENLEY PHONE NO : 901 399 6487 1450 BROOKS RD. SE DECISION MADE: 12-JUL-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLANAS AVALON POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K111076(TRADITIONAL) ATTN: KARLA SCHAFFNER PHONE NO : 760 494 6739 5818 EL CAMINO REAL SE DECISION MADE: 12-JUL-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR MEDICA CORP. 510(k) NO: K101089(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 13-JUL-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: CARDIAC SCANNER AND PROCESSING SYSTEM SPECTRUM DYNAMICS (ISRAEL) LTD. 510(k) NO: K110507(TRADITIONAL) ATTN: ILAN SHARON PHONE NO : 972 53 8704904 1 HA'RAKEFET ST. SE DECISION MADE: 13-JUL-11 ZICHRON YAACOV IS 30900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES W.A. RUBBERMATE CO., LTD. 510(k) NO: K110418(TRADITIONAL) ATTN: TERENCE LIM SIN KOOI PHONE NO : 662 318 9442 NONGMAIDAENG SE DECISION MADE: 13-JUL-11 A. MAUNG, CHONBURI TH 20000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX KNEE SYSTEM, APEX ALL POLY TIBIA OMNILIFE SCIENCE INC. 510(k) NO: K111062(TRADITIONAL) ATTN: CHRISTINE NASSIF PHONE NO : 774 226 1871 50 O'CONNELL WAY SUITE #10 SE DECISION MADE: 13-JUL-11 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANOURA 18S THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K111231(TRADITIONAL) ATTN: FUMIAKI KANAI PHONE NO : 011 813 38188577 4-1-17 HONGO, BUNKYO-KU SE DECISION MADE: 13-JUL-11 TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANTEVIEW SEHYUN CO., LTD. 510(k) NO: K111312(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK STREET UNIT J SE DECISION MADE: 13-JUL-11 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG PEN MERIDIAN DYNAMICS BIOMEDICAL, INC 510(k) NO: K103077(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 863 8140 2904 N. BOLDT DRIVE SE DECISION MADE: 13-JUL-11 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS SPINE PEDICLE SCREW SYSTEM ATLAS SPINE INC. 510(k) NO: K110842(SPECIAL) ATTN: JEANNETTE G DAILEY PHONE NO : 561 354 4319 1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 13-JUL-11 JUPITER FL 33458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACCESS PTA DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K111850(TRADITIONAL) ATTN: CANDACE WADE PHONE NO : 480 303 2662 1625 WEST 3RD ST SE DECISION MADE: 13-JUL-11 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K111652(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 13-JUL-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUPRO MESSENGER BALLOON CATHETER CARDIOSOLUTIONS INC 510(k) NO: K094048(TRADITIONAL) ATTN: MICHELE LUCEY PHONE NO : 781 344 0801 75 MILL STREET SE DECISION MADE: 14-JUL-11 STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE KOON SENG SDN.BHD 510(k) NO: K110960(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 14-JUL-11 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA 510(k) NO: K111034(SPECIAL) ATTN: KAREN THOMISON PHONE NO : 615 833 2633 5209 LINDBAR DRIVE SUITE 640 SE DECISION MADE: 14-JUL-11 NASHVILLE TN 37167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K111240(ABBREVIATED) ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 14-JUL-11 RANCHO CUCAMONGA CA 91739 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARA DIAGNOS, INC 510(k) NO: K110869(TRADITIONAL) ATTN: ARON SHAPIRO PHONE NO : 978 685 8900 300 BRICKSTONE SQUARE SE DECISION MADE: 14-JUL-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOFUSE DENTAL IMPLANT SYSTEM DYNAMIC INNOVATIONS INC. 510(k) NO: K110577(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE STREET UNIT B SE DECISION MADE: 14-JUL-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER SYRINGES AND NEEDLES TIGER MEDICAL PRODUCTS LTD 510(k) NO: K110697(TRADITIONAL) ATTN: DAVID WANG PHONE NO : 862 163 866300 1 HUAIHAI ZHONG ROAD LIU LIN TOWERSE DECISION MADE: 14-JUL-11 SHANGHAI CH 200021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP. DBA STRY510(k) NO: K111065(TRADITIONAL) ATTN: CALUDIA WIESEMANN PHONE NO : 325 CORPORATE DRIVE SE DECISION MADE: 14-JUL-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER NEPHROS, INC. 510(k) NO: K110285(SPECIAL) ATTN: JAMES SUMMERTON PHONE NO : 201 343 5202 41 GRAND AVE. SE DECISION MADE: 14-JUL-11 RIVER EDGE NJ 07661 510(k) STATEMENT DEVICE: SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE APOTHECARY PRODUCTS, INC. 510(k) NO: K111856(TRADITIONAL) ATTN: JAMES JENKINS PHONE NO : 952 808 8364 11750 12TH AVE. SOUTH SE DECISION MADE: 14-JUL-11 BURNSVILLE MN 55337 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OPIATE ENZYME IMMUNOASSAY LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K110298(TRADITIONAL) ATTN: BERNICE LIN PHONE NO : 408 732 3856 670 ALMANOR AVENUE SE DECISION MADE: 15-JUL-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. 510(k) NO: K093755(TRADITIONAL) ATTN: YI LIU PHONE NO : 862 287 612426 NO. 04-23-3 AIRPORT INDUSTRIAL PARSE DECISION MADE: 15-JUL-11 TIANJIN CH 300381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY ANALYSIS SCALE, MODEL BG 17 SHENZHEN HEALTHCARE ELECTRONIC TEC510(k) NO: K110928(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 15-JUL-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR SHANDONG ZHANPENG MEDICAL PRODUCTS510(k) NO: K110857(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 15-JUL-11 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRO FAMILY OF MANUAL WHEELCHAIRS OTTO BOCK HEALTHCARE, LP 510(k) NO: K111045(TRADITIONAL) ATTN: WILLIAM KABITZ PHONE NO : 763 553 9464 2 CARLSON PKWY., SUITE 100 SE DECISION MADE: 15-JUL-11 MINNEAPOLIS MN 55447 4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMR SHOULDER SYSTEM - CTA HUMERAL HEADS LIMACORPORATE S.P.A. 510(k) NO: K110847(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 P.O. BOX 696 SE DECISION MADE: 15-JUL-11 WINONA LAKE IN 46590 696 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACG-8511 PORTABLE ECG MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K110328(TRADITIONAL) ATTN: LIU YI PHONE NO : 862 260 526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 15-JUL-11 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. 510(k) NO: K102643(TRADITIONAL) ATTN: JASON C REYNOLDS PHONE NO : 503 657 3010 15130 S.E. 82ND DR. SE DECISION MADE: 15-JUL-11 CLACKAMAS OR 97015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA BEIJING RONGRUI-CENTURY SCIE. & TE510(k) NO: K103685(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 15-JUL-11 SHANGAHI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH GIBRALT SPINAL SYSTEM EXACTECH, INC. 510(k) NO: K110197(TRADITIONAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 15-JUL-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES GX CORPORATION SDN BHD 510(k) NO: K111328(TRADITIONAL) ATTN: GANESAN SUPIRAMUNIAM PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA JALASE DECISION MADE: 15-JUL-11 KLANG, SELANGOR MY 42100 510(k) STATEMENT DEVICE: WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K111560(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 15-JUL-11 GAITHERSBRUG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-SCAN ESAOTE, S.P.A. 510(k) NO: K111803(SPECIAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 15-JUL-11 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, INC. 510(k) NO: K111417(SPECIAL) ATTN: ALBERT MISAJON PHONE NO : 858 259 8333 12526 HIGH BLUFF DRIVE SUITE 360 SE DECISION MADE: 15-JUL-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM VOLCANO CORPORATION 510(k) NO: K111706(SPECIAL) ATTN: JWALA JAWHARKAR PHONE NO : 916 281 2925 2870 KILGORE RD. SE DECISION MADE: 15-JUL-11 RANCHO CORDOVA CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 9 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K111864(TRADITIONAL) ATTN: YUCHI CHU PHONE NO : 425 949 4907 SUITE 226, 10604 NE 38TH PLACE SE DECISION MADE: 15-JUL-11 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FALCON VIASONIX LTD. 510(k) NO: K111416(TRADITIONAL) ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 15-JUL-11 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR MEDIVANCE, INC. 510(k) NO: K110956(TRADITIONAL) ATTN: LYNNE ARONSON PHONE NO : 303 926 1917 321 SOUTH TAYLOR AVE, STE 200 SE DECISION MADE: 18-JUL-11 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROSURGICAL INSTRUMENT ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K110189(TRADITIONAL) ATTN: AMANDA BABCOCK PHONE NO : 480 763 5376 10232 SOUTH 51ST STREET SE DECISION MADE: 18-JUL-11 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLELASE FAMILY OF LASERS CANDELA CORP. 510(k) NO: K111144(TRADITIONAL) ATTN: SCOTT BLOOD PHONE NO : 508 358 7400 530 BOSTON POST ROAD SE DECISION MADE: 18-JUL-11 WAYLAND MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ENDOSCOPIC TROCARS STERILMED, INC. 510(k) NO: K111002(TRADITIONAL) ATTN: GARRETT AHLBORG PHONE NO : 763 488 3483 11400 73RD AVE. NORTH SE DECISION MADE: 18-JUL-11 MAPLE GROVE MN 55369 5562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. 510(k) NO: K110439(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801 924 4958 1370 SOUTH 2100 EAST SE DECISION MADE: 18-JUL-11 SALT LAKE SITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSTONE R SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K103731(TRADITIONAL) ATTN: THAO PHAN PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 18-JUL-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEL-CAT TAKARA BELMONT CORP. 510(k) NO: K101181(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO COURT SE DECISION MADE: 19-JUL-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 IMMUNO-MYCOLOGICS, INC. 510(k) NO: K101407(TRADITIONAL) ATTN: SEAN K BAUMAN, PH.D PHONE NO : 405 360 4669 2700 TECHNOLOGY PLACE SE DECISION MADE: 19-JUL-11 NORMAN OK 73071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K103676(TRADITIONAL) ATTN: DIANA LYN DICKSON PHONE NO : 610 240 3917 201 GREAT VALLEY PKWY. SE DECISION MADE: 19-JUL-11 MALVERN PA 19355 1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI TELEMETRY SYSTEM WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K110556(TRADITIONAL) ATTN: AGATA SMIEJA PHONE NO : 410 456 0329 8880 GOMAN ROAD SE DECISION MADE: 19-JUL-11 LAUREL MD 20723 5800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE VESSEL CANNULA MEDLINE, INDUSTRIES, INC. 510(k) NO: K111147(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 19-JUL-11 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD INSYTE AUTOGUARD BC BECTON DICKINSON & CO. 510(k) NO: K110443(TRADITIONAL) ATTN: RAND PUGMIRE PHONE NO : 801 565 2550 9450 SOUTH STATE STREET SE DECISION MADE: 19-JUL-11 SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTROPY EASYFIT SENSOR GE HEALTHCARE 510(k) NO: K103129(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781 449 8685 86 PILGRIM ROAD SE DECISION MADE: 19-JUL-11 NEEDHAM MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOLPHIN 3 FLUID MANAGEMENT SYSTEM GYRUS ACMI, INC. 510(k) NO: K110852(TRADITIONAL) ATTN: GRAHAM BAILLIE PHONE NO : 508 804 2738 136 TURNPIKE RD. SE DECISION MADE: 19-JUL-11 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMA XR120 GE MEDICAL SYSTEMS, LLC 510(k) NO: K111304(SPECIAL) ATTN: NIDHI CHAUDHARY PHONE NO : 414 721 2899 3000 N GRANDVIEW BLVD. SE DECISION MADE: 19-JUL-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAXXSD SYSTEM SPINE WAVE, INC. 510(k) NO: K111469(SPECIAL) ATTN: DENISE DUCHENE PHONE NO : 203 712 1847 3 ENTERPRISE DR SUITE 210 SE DECISION MADE: 19-JUL-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K WILSON-COOK MEDICAL INC. 510(k) NO: K111495(TRADITIONAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336 744 0157 4900 Bethania Station Rd SE DECISION MADE: 19-JUL-11 WINSTON-SALEM NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURON MAX SYSTEM PENUMBRA, INC. 510(k) NO: K111380(SPECIAL) ATTN: MICHAELA MAHL PHONE NO : 510 748 3288 1351 HARBOR BAY PARKWAY SE DECISION MADE: 19-JUL-11 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL90 RADIOMETER MEDICAL APS 510(k) NO: K111897(SPECIAL) ATTN: MARTIN GABLER PHONE NO : 45 382 73114 AAKANDEVEJ 21 SE DECISION MADE: 19-JUL-11 COPENHAGEN DA 2100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILEDIAGNOST WDR SEDECAL SA 510(k) NO: K111725(SPECIAL) ATTN: JENNIFER CARTLEDGE PHONE NO : 864 506 0097 409 WOODRIDGE DR SE DECISION MADE: 19-JUL-11 SENECA SC 29672 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATEAU SPACER SYSTEM LIFE SPINE, INC 510(k) NO: K111835(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 19-JUL-11 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE LPL (HUI ZHOU) GLOVE CO., LTD. 510(k) NO: K111598(ABBREVIATED) ATTN: CAMILLE D THORNTON PHONE NO : 757 224 0177 144 RESEARCH DRIVE SE DECISION MADE: 20-JUL-11 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIE A1C TEST SYSTEM MEC DYNAMICS CORP 510(k) NO: K093548(TRADITIONAL) ATTN: EMMANUEL MPOCK PHONE NO : 408 428 9721 90 ROSE ORCHARD WAY SE DECISION MADE: 20-JUL-11 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRAG LATERAL FLOW ASSAY (CRAG LFA) IMMUNO-MYCOLOGICS, INC. 510(k) NO: K102286(TRADITIONAL) ATTN: SEAN BAUMAN PHONE NO : 405 360 4669 2700 TECHNOLOGY PLACE SE DECISION MADE: 20-JUL-11 NORMAN OK 73071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERI-DENT, STERI-SURE CPAC, INC. 510(k) NO: K110867(TRADITIONAL) ATTN: JEFFREY S CRANE PHONE NO : 585 383 3223 2364 LEICESTER RD. P.O. BOX 175 SE DECISION MADE: 20-JUL-11 LEICESTER NY 14481 0175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMA CT660 GE MEDICAL SYSTEMS, LLC 510(k) NO: K110227(SPECIAL) ATTN: TRACEY ORTIZ PHONE NO : 414 544 3206 3000 N GRANDVIEW BLVD. SE DECISION MADE: 20-JUL-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEVOFLURANE VAPORIZER ADAPTOR PIRAMAL CRITCAL CARE, INC (FORMERL510(k) NO: K110608(TRADITIONAL) ATTN: JAMIE KELLER PHONE NO : 610 974 9760 50 COBHAM DRIVE SE DECISION MADE: 20-JUL-11 ORCHARD PARK NY 14127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMMUNIFY PACS VIEWER FLYING SQUIRREL STORAGE LLC 510(k) NO: K110797(TRADITIONAL) ATTN: CHRIS RELYEA PHONE NO : 646 526 7111 160 W 71ST, FLOOR 18 SE DECISION MADE: 20-JUL-11 NEW YORK NY 10023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) ENCORE MEDICAL, L.P. 510(k) NO: K111061(SPECIAL) ATTN: TEFFANY HUTTO PHONE NO : 512 834 6225 9800 METRIC BLVD. SE DECISION MADE: 20-JUL-11 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMI IMPLANT; MINI HEMI IMPLANT VILEX, INC. 510(k) NO: K102401(TRADITIONAL) ATTN: SYLVIA SOUTHARD PHONE NO : 931 474 7550 111 MOFFITT STREET SE DECISION MADE: 20-JUL-11 MCMINNVILLE TN 37110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K103745(TRADITIONAL) ATTN: WENDY A MCMANUS PHONE NO : 973 889 4415 1500 LITTLETON ROAD SE DECISION MADE: 20-JUL-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. 510(k) NO: K110213(TRADITIONAL) ATTN: JIM RASKOB PHONE NO : 608 221 1551 PO BOX 7550 3030 OHMEDA DR. SE DECISION MADE: 20-JUL-11 MADISON WI 53707 7550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR EDAN INSTRUMENTS, INC. 510(k) NO: K110922(TRADITIONAL) ATTN: RANDY JIANG PHONE NO : 867 552 6899197 3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 20-JUL-11 SHENZHEN, GUANGDONG CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAP CANNULATED SCREWS AAP IMPLANTATE AG 510(k) NO: K111316(SPECIAL) ATTN: MARC SEEGERS PHONE NO : 49 30 75019192 LORENZWEG 5 SE DECISION MADE: 20-JUL-11 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDITE ZIRCONIA DENTAL CERAMICS QINHUANGDAO AIDITE HIGH-TECHNICAL 510(k) NO: K111291(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 20-JUL-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN (R) MICROSTREP PLUS (R) PANELS SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K111205(TRADITIONAL) ATTN: SHANNON POPSON PHONE NO : 916 374 3330 1584 ENTERPRISE BLVD. SE DECISION MADE: 20-JUL-11 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXXENT RADIATION SHIELD - RIGID XOFT, AN ICAD COMPANY 510(k) NO: K111299(TRADITIONAL) ATTN: STEVE LIN PHONE NO : 408 419 2300 345 POTRERO AVENUE SE DECISION MADE: 20-JUL-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 ARTHROCARE CORP. 510(k) NO: K111399(SPECIAL) ATTN: LAURA KASPEROWICZ PHONE NO : 949 585 2406 15285 ALTON PARKWAY SUITE 200 SE DECISION MADE: 20-JUL-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY MODEL 07XXXX CUSTOM SPINE 510(k) NO: K111774(SPECIAL) ATTN: SAAD ATTIYAH PHONE NO : 973 808 0019 1140 PARSIPPANY BLVD, SUITE 20 SE DECISION MADE: 20-JUL-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER ICOTEC 510(k) NO: K100305(TRADITIONAL) ATTN: BARBARA ATZENHOEFER STEGMEIPHONE NO : 763 588 9836 4050 OLSON MEMORIAL HIGHWAY SUITE SE DECISION MADE: 21-JUL-11 MINNEAPOLIS MN 55422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESYS SPINE TILOCK SYSTEM GENESYS SPINE 510(k) NO: K103671(SPECIAL) ATTN: BRIAN J BERGERON PHONE NO : 512 381 7071 1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 21-JUL-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110970(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 21-JUL-11 RD. HAI DI, BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CI-SNAP WOUND CARE SYSTEM SPIRACUR, INC. 510(k) NO: K111006(TRADITIONAL) ATTN: SARAH CANIO PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 21-JUL-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEPMINDER BREATHING FREQUENCY INDICATOR BIANCAMED LIMITED 510(k) NO: K103631(TRADITIONAL) ATTN: PAUL PHILLIPS PHONE NO : 353 171 63755 NOVAUCD, BELFIELD INNOVATION P UNISE DECISION MADE: 21-JUL-11 BELFIELD, DUBLIN EI 4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLOR RADIAL HEAD PLATING SYSTEM BIOMET, INC. 510(k) NO: K110201(TRADITIONAL) ATTN: PATRICIA S BERES PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 21-JUL-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFUSION SET FOR POWERPICC SOLO 2 CATHETER C.R. BARD, INC. 510(k) NO: K102405(TRADITIONAL) ATTN: LYNN M KIRCHOFF PHONE NO : 801 522 5636 605 NORTH 5600 WEST SE DECISION MADE: 21-JUL-11 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COREN TOTAL HIP SYSTEM CORENTEC CO., LTD 510(k) NO: K103431(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 21-JUL-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K103831(TRADITIONAL) ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 21-JUL-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE OBI BIOLOGICS, INC. 510(k) NO: K101453(TRADITIONAL) ATTN: DUSTYN WEBB PHONE NO : 806 796 1923 4620 71ST STREET, BLDG 79 SE DECISION MADE: 21-JUL-11 LUBBOCK TX 79424 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110966(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 21-JUL-11 RD. HAI DI CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT KCI USA, INC. 510(k) NO: K111280(TRADITIONAL) ATTN: MARGARET MARSH PHONE NO : 210 255 6481 6203 FARINON DR. SE DECISION MADE: 21-JUL-11 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSC/ALF SPINAL SYSTEM SINTEA PLASTEK, LLC 510(k) NO: K101886(TRADITIONAL) ATTN: DANIELLE WERNIKOWSKI PHONE NO : 305 673 6226 407 LINCOLN ROAD SUITE 101 SE DECISION MADE: 21-JUL-11 MIAMI BEACH FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM BIOMET MANUFACTURING CORP. 510(k) NO: K110320(TRADITIONAL) ATTN: PATRICIA S BERES PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 21-JUL-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS T3 CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K111552(TRADITIONAL) ATTN: KELLY FRENCH PHONE NO : 317 521 3208 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 21-JUL-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM ZYGA TECHNOLOGY, INC. 510(k) NO: K111801(TRADITIONAL) ATTN: DIANE BRINZA PHONE NO : 612 455 1061 700 10TH AVENUE SOUTH, SUITE 400 SE DECISION MADE: 21-JUL-11 MINNEAPOLIS MN 55415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REXIOUS SPINAL FIXATION SYSTEM DIO MEDICAL CO., LTD. 510(k) NO: K111362(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 21-JUL-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METASURG DIGIFUSE IMPLANT METASURG 510(k) NO: K111536(TRADITIONAL) ATTN: JOSHUA SCOTT PHONE NO : 281 398 5656 16350 PARK TEN PL., SUITE 101 SE DECISION MADE: 21-JUL-11 HOUSTON TX 77084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD 510(k) NO: K111750(SPECIAL) ATTN: CLAY ANSELMO PHONE NO : 303 223 4303 11925 WEST I-70 FRONTAGE RD NORTH SE DECISION MADE: 21-JUL-11 CLAY ANSELMO CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAESTRO WRIST PLATING SYSTEM BIOMET MANUFACTURING CORP. 510(k) NO: K110271(TRADITIONAL) ATTN: PATRICIA S BERES PHONE NO : 574 267 6639 56 BELL DRIVE SE DECISION MADE: 22-JUL-11 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOFLIP GASTRIC TUBE CROSPON, LTD. 510(k) NO: K110529(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 22-JUL-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRYLIC HERBST APPLIANCE EMBASSY DENTAL LABORATORY 510(k) NO: K111009(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 22-JUL-11 CHESTERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ E9 GE HEALTHCARE 510(k) NO: K110943(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE RP-2138 SE DECISION MADE: 22-JUL-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APNEA GUARD ADVANCED BRAIN MONITORING, INC. 510(k) NO: K111110(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 22-JUL-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS CERVICAL SPINAL FIXATION SYSTEM L&K BIOMED CO.,LTD. 510(k) NO: K103414(TRADITIONAL) ATTN: SUN YI LEE PHONE NO : 822 262 41471 #1104 ACE HIGH-END TOWER 3 CHA 371SE DECISION MADE: 22-JUL-11 SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTOGRAPH EVO 3D VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K111152(ABBREVIATED) ATTN: PAOLO CASAGRANDE SANTIN PHONE NO : 390 248 8591 VIA DELLE AZALEE 3 SE DECISION MADE: 22-JUL-11 BUCCINASCO IT 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL CAGE EISERTECH, LLC 510(k) NO: K110915(ABBREVIATED) ATTN: LUKAS EISERMANN PHONE NO : 888 262 2817 2555 FRONT STREET SE DECISION MADE: 22-JUL-11 SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIM E30 II CO2 LASER LASERING S.R.L. 510(k) NO: K110984(SPECIAL) ATTN: ALLEN R HOWES PHONE NO : 925 355 0750 2246 CAMINO RAMON SE DECISION MADE: 22-JUL-11 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIAC TRIGGER MONITOR IVY BIOMEDICAL SYSTEMS, INC. 510(k) NO: K110987(SPECIAL) ATTN: DICK LISTRO PHONE NO : 203 481 4183 11 BUSINESS PARK DR. SE DECISION MADE: 22-JUL-11 BRANFORD CT 06405 510(k) STATEMENT DEVICE: MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. 510(k) NO: K111302(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 22-JUL-11 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUFF SENTRY VENTLAB CORP. 510(k) NO: K102674(TRADITIONAL) ATTN: JAMES COCHIE PHONE NO : 336 753 5000 155 BOYCE DRIVE SE DECISION MADE: 22-JUL-11 MOCKSVILLE NC 27028 510(k) STATEMENT DEVICE: RE / STASIS (TM) GINGIVAL RETRACTION PASTE CENTRIX, INC. 510(k) NO: K111348(TRADITIONAL) ATTN: JOHN DISCKO PHONE NO : 203 567 7426 770 RIVER RD. SE DECISION MADE: 22-JUL-11 SHELTON CT 06484 5458 510(k) STATEMENT DEVICE: MP 719 MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K111524(TRADITIONAL) ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781 270 3200 107 WATER ST. SE DECISION MADE: 22-JUL-11 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K111631(TRADITIONAL) ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 22-JUL-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K111866(SPECIAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 22-JUL-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM GOLD STANDARD ORTHOPEDICS LLC 510(k) NO: K110990(TRADITIONAL) ATTN: JAMES RITTER PHONE NO : 574 527 3256 3415 N. OLD FARM RD. E. SE DECISION MADE: 25-JUL-11 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION ONE LASER SYSTEM LUMENIS INC. 510(k) NO: K111213(SPECIAL) ATTN: JACE R MCLANE PHONE NO : 801 656 2329 3959 WEST 1820 SOUTH SE DECISION MADE: 25-JUL-11 SALT LAKE CITY UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CXI TRIFORCE COOK INCORPORATED 510(k) NO: K111263(TRADITIONAL) ATTN: MOLLY BUSENBARK PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 25-JUL-11 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIXTAL DZ-4100 SERIES PULSE OXIMETER DIXTAL MEDICAL, INC. 510(k) NO: K103285(SPECIAL) ATTN: ROBERT H SCHIFFMAN PHONE NO : 203 269 1112 101 N. Plains Industrial Rd. SE DECISION MADE: 25-JUL-11 Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCUMAURAL ADHESIVE REPLACEMENT R & D MEDICAL PRODUCTS, INC. 510(k) NO: K111555(TRADITIONAL) ATTN: JAMES PERRAULT PHONE NO : 949 472 9346 20492 CRESCENT BAY DR. #106 SE DECISION MADE: 25-JUL-11 LAKE FOREST CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.7MM/5.0MM DYNAMIC LOCKING SCREW SYNTHES USA 510(k) NO: K110592(TRADITIONAL) ATTN: CHRISTOPHER HACK, ESQ PHONE NO : 610 719 6940 1301 GOSHEN PKWY SE DECISION MADE: 25-JUL-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYBRID PICA WHOLE-BODY MRI SYSTEM TIME MEDICAL LIMITED 510(k) NO: K110942(ABBREVIATED) ATTN: JOHN BABY PHONE NO : 852 215 61711 NO. 2 SCIENCE PARK WEST AVE. SHATISE DECISION MADE: 26-JUL-11 HONG KONG CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX SPINE SYSTEM SPINECRAFT LLC 510(k) NO: K110906(TRADITIONAL) ATTN: AMI AKALLAL-ASAAD PHONE NO : 708 531 9700 2215 ENTERPRISE DRIVE SUITE 1504 SE DECISION MADE: 26-JUL-11 WESTCHESTER IL 60154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATCH, PLEDGET AND INTRACARDIAC CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K111187(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155 MOFFETT PARK DRIVE SUITE 210 SE DECISION MADE: 26-JUL-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRATED INNOVA - S5I SYSTEM OPTION GE HEALTHCARE 510(k) NO: K111209(TRADITIONAL) ATTN: FAYCAL KHERRA PHONE NO : 330 130 704082 283, RUE DE LA MINIERE SE DECISION MADE: 26-JUL-11 BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCIS ACTIVON TUBE CALIDAD SOLUTIONS, INC. 510(k) NO: K101114(TRADITIONAL) ATTN: JOHN BILLINGS PHONE NO : 206 575 7762 22433 72 AVENUE S SE DECISION MADE: 26-JUL-11 KENT WA 98032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ S8 GE HEALTHCARE 510(k) NO: K111582(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE MAIL STOP RPSE DECISION MADE: 26-JUL-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K111388(TRADITIONAL) ATTN: MEGAN M BRANDT PHONE NO : 651 259 2805 651 CAMPUS DR. SE DECISION MADE: 26-JUL-11 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUE SAMPLING NEEDLE UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103694(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 27-JUL-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD AUTOSHIELD DUO PEN NEEDLE BECTON, DICKINSON AND COMPANY 510(k) NO: K110703(TRADITIONAL) ATTN: CYNTHIA LACATENA PHONE NO : 201 847 6869 1 BECTON DRIVE MC 372 SE DECISION MADE: 27-JUL-11 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K110156(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 27-JUL-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY DERMA SCIENCES, INC. 510(k) NO: K110546(TRADITIONAL) ATTN: RONALD S WARREN PHONE NO : 858 753 1961 11440 W. BERNARDO COURT, SUITE 300SE DECISION MADE: 27-JUL-11 SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG JIANHONG NEW MATERIAL COM510(k) NO: K111752(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG, 1 JIAN XIANG YUAN SE DECISION MADE: 27-JUL-11 HUAN ZHONG RD, BEIJING CH 10083510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI NIDEK CO., LTD. 510(k) NO: K111493(TRADITIONAL) ATTN: MICHAEL J BILLIG PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SUITE 100 SE DECISION MADE: 27-JUL-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF MEDTRONIC INC. 510(k) NO: K111972(SPECIAL) ATTN: JESSICA SIXBERRY PHONE NO : 763 514 8949 7611 NORTHLAND DRIVE SE DECISION MADE: 27-JUL-11 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI PHARMAJET, INC. 510(k) NO: K111517(SPECIAL) ATTN: MICHAEL J RYAN PHONE NO : 303 526 4278 400 CORORATE CIRCLE, SUITE N SE DECISION MADE: 27-JUL-11 GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE TELCARE, INC. 510(k) NO: K110571(TRADITIONAL) ATTN: JONATHAN C JAVITT PHONE NO : 240 396 6003 3 BETHESDA METRO CENTER SUITE 430 SE DECISION MADE: 28-JUL-11 BETHESDA MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K110723(SPECIAL) ATTN: SHELLY HARRIS PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 28-JUL-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREGNANCY ONE STEP RAPID TEST LEHNUS & ASSOCIATES CONSULTING 510(k) NO: K103574(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD. SE DECISION MADE: 28-JUL-11 EAST STROUDSBURG PA 18301 8804 510(k) STATEMENT DEVICE: SMR SHOULDER SYSTEM- REVISION STEMS LIMACORPORATE S.P.A. 510(k) NO: K111212(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 P.O. BOX 696 SE DECISION MADE: 28-JUL-11 WINONA LAKE IN 46590 696 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR PARCUS MEDICAL, LLC 510(k) NO: K111000(TRADITIONAL) ATTN: BARTON BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 28-JUL-11 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE WET NOSE TECHNOLOGIES, LLC 510(k) NO: K111191(SPECIAL) ATTN: LIONEL NEWMAN PHONE NO : 323 733 0406 3750 2ND AVE SE DECISION MADE: 28-JUL-11 LOS ANGELES CA 90018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI-Q SYSTEM RESONANCE HEALTH ANALYSIS SERVICES510(k) NO: K111222(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 28-JUL-11 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES STERNAL ZIPFIX SYSTEM SYNTHES (USA) 510(k) NO: K110789(TRADITIONAL) ATTN: ANDREA M TASKER PHONE NO : 610 719 6290 1301 GOSHEN PARKWYA SE DECISION MADE: 28-JUL-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS SOFLEX LIMITED 510(k) NO: K110261(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 28-JUL-11 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: XELIS 3D INFINITT CO., LTD. 510(k) NO: K103130(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940 300 8601 1600 MANCHESTER WAY SE DECISION MADE: 28-JUL-11 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: N-FORCE FIXATION SYSTEM INNOVISION, INC. 510(k) NO: K102528(TRADITIONAL) ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 28-JUL-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT EXACTECH, INC. 510(k) NO: K111400(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 N.W. 66TH CT. SE DECISION MADE: 28-JUL-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENNER TRACHEAL SEAL MONITOR VENNER MEDICAL (SINGAPORE) PTE LTD510(k) NO: K110631(TRADITIONAL) ATTN: HCHRISTINE BRAUER, PH.D. PHONE NO : 301 545 1990 7 TRAIL HOUSE COURT SE DECISION MADE: 28-JUL-11 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY VALVE ENDOCHOICE, INC. 510(k) NO: K111821(TRADITIONAL) ATTN: THERON GOBER PHONE NO : 678 534 6021 11810 WILLS ROAD SUITE 100 SE DECISION MADE: 28-JUL-11 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP (R) WOUND CARE SYSTEM SPIRACUR, INC. 510(k) NO: K111393(SPECIAL) ATTN: SARAH CANIO PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SUITE 100 SE DECISION MADE: 28-JUL-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREAVIEW SOFTWARE 6.1 VITAL IMAGES, INC. 510(k) NO: K111892(TRADITIONAL) ATTN: IAN NEMEROV PHONE NO : 952 487 9622 5850 OPUS PARKWAY, SUITE 300 SE DECISION MADE: 28-JUL-11 MINNETONKA MN 55343 4414 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTELLISPACE PACS 4.X PHILIPS HEALTHCARE INFORMATICS, IN510(k) NO: K111804(TRADITIONAL) ATTN: VICTORIA S MACKINNON PHONE NO : 650 293 2373 4100 EAST THIRD AVE, STE 101 SE DECISION MADE: 28-JUL-11 FOSTER CITY CA 94404 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS STRYKER SPINE 510(k) NO: K110419(TRADITIONAL) ATTN: TIFFANI D ROGERS PHONE NO : 201 760 8206 2 PEARL COURT SE DECISION MADE: 28-JUL-11 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN COLLAGEN MATRIX, INC. 510(k) NO: K110600(TRADITIONAL) ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 15 THORNTON ROAD SE DECISION MADE: 29-JUL-11 OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K103740(TRADITIONAL) ATTN: DAVID L ROSEN, B.S. PHARM., PHONE NO : 202 672 5430 3000 K ST., NW SE DECISION MADE: 29-JUL-11 WASHINGTON DC 20007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PE-210AK SWITCH BOX NIHON KOHDEN CORP. 510(k) NO: K110376(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 29-JUL-11 FOOTHILL CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR HANDELSHAUS DITTMAN GMBH 510(k) NO: K110390(TRADITIONAL) ATTN: KANG JIANG PING PHONE NO : 867 552 7652471 NO.3 BUILDING,XILIYIANGGUANG INDUSSE DECISION MADE: 29-JUL-11 SHENZHEN CH 518108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN BUDDY BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K102051(TRADITIONAL) ATTN: GARY BUSSETT PHONE NO : 760 727 5600 P.O. BOX 1360 SE DECISION MADE: 29-JUL-11 VISTA CA 92085 1360 510(k) STATEMENT DEVICE: JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) JIANGSU SHENLI MEDICAL PRODUCTION 510(k) NO: K103830(ABBREVIATED) ATTN: DARREN REEVES PHONE NO : 804 307 7706 15637 FOX COVE CIRCLE SE DECISION MADE: 29-JUL-11 MOSELY VA 23120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIODENTA CUSTOMIZED ABUTMENT BIODENTA SWISS AG 510(k) NO: K110778(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 TRAMSTRASSE 16 SE DECISION MADE: 29-JUL-11 BERNECK SZ 9442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTNAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K111245(ABBREVIATED) ATTN: LYNN HARMER PHONE NO : 425 487 7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 29-JUL-11 BOTHELL WA 98021 8431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSI O-BALL ABUTMENT HEAD IMPLANTS JUELL DENTAL 510(k) NO: K110548(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 2401 N COMMERCE SE DECISION MADE: 29-JUL-11 ARDMORE OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOMAXX FULLY COVERED ESOPHAGEAL STENT MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K111611(SPECIAL) ATTN: JOHN C KNORPP PHONE NO : 801 208 4389 1600 WEST MERIT PKWY. SE DECISION MADE: 29-JUL-11 SOUTH JORDAN UT 84095 2415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDECROSS SUPPORT CATHETER TERUMO MEDICAL CORP. 510(k) NO: K111556(TRADITIONAL) ATTN: MARK UNTERREINER PHONE NO : 410 392 7213 950 ELKTON BLVD. SE DECISION MADE: 29-JUL-11 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER PERITONEAL DIALYSIS SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K103220(TRADITIONAL) ATTN: ROGER A LEROUX PHONE NO : 603 669 5139 340 COMMERCIAL ST. SE DECISION MADE: 29-JUL-11 MANCHESTER NH 03101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO WARMING CABINET STERIS CORPORATION 510(k) NO: K111870(SPECIAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 29-JUL-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY NAVILYST MEDICAL, INC. 510(k) NO: K111906(SPECIAL) ATTN: LORRAINE M HANLEY PHONE NO : 508 658 7945 26 FOREST STREET SE DECISION MADE: 29-JUL-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. 510(k) NO: K111884(SPECIAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 2ND AVENUE SE DECISION MADE: 29-JUL-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH MEDPRO SAFETY PRODUCTS, INC. 510(k) NO: K111424(SPECIAL) ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 29-JUL-11 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- INSERT MOLDING SOLUTIONS, INC 510(k) NO: K111529(TRADITIONAL) ATTN: PAUL HENDRIXSON PHONE NO : 678 965 5334 4325 SETTINGDOWN CIRCLE SUITE 103 SE DECISION MADE: 29-JUL-11 CUMMING GA 30028 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 226 TOTAL WITH SUMMARIES 212 TOTAL WITH STATEMENTS 14
-
-
