
March 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD March 2012 DEVICE: OASYS SURGICAL LIGHT CONTROLLER OASYS HEALTHCARE 510(k) NO: K112133(TRADITIONAL) ATTN: TANYA M O'BRIEN PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 01-MAR-12 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FD TENS 2070 FUJI DYNAMICS LTD 510(k) NO: K111654(TRADITIONAL) ATTN: CHING KONG (FELIX) LEE PHONE NO : 852 27 864218 UNIT 1-3, 23/F LAWS COMMERICAL PLASE DECISION MADE: 01-MAR-12 HONG KONG CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APNEARX APNEA SCIENCE CORPORATION 510(k) NO: K113569(ABBREVIATED) ATTN: GARY MOCNIK PHONE NO : 949 433 0413 49 COASTAL OAK SE DECISION MADE: 01-MAR-12 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSPORT CULTURE MEDIUM DEVICE PURITAN MEDICAL PRODUCTS LLC 510(k) NO: K113249(TRADITIONAL) ATTN: MEHDI KARAMCHI PHONE NO : 207 876 3311 31 SCHOOL STREET P.O. BOX 149 SE DECISION MADE: 01-MAR-12 GUILFORD ME 04443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYING"SONO"/SONOLONG" PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K113188(TRADITIONAL) ATTN: CHRISTIAN G QUASS PHONE NO : 497 704 9291 KARL-HALL-STRASSE 1 SE DECISION MADE: 01-MAR-12 GEISINGEN GM 78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE CHENGDU XINJIN SHIFENG MED APPRATU510(k) NO: K111841(TRADITIONAL) ATTN: XINGLONG TIAN PHONE NO : 862 862 812121 WANJIE VILLAGE, XINPING TOWN, XINJSE DECISION MADE: 01-MAR-12 CHENGDU CITY CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUCLID (TM) TIER 1-GW ACCESS SYSTEM HOUSTON MEDICAL ROBOTICS 510(k) NO: K111426(TRADITIONAL) ATTN: DARLA J ELKIN PHONE NO : 281 450 8163 42 NORTH CHANTSONG CIRCLE SE DECISION MADE: 01-MAR-12 THE WOODLANDS TX 77382 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... ASTRA TECH INC. 510(k) NO: K113003(TRADITIONAL) ATTN: BETSY A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERRACE SE DECISION MADE: 01-MAR-12 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET MAGNA DIREX SYSTEMS CORP. 510(k) NO: K111947(TRADITIONAL) ATTN: LARISA GERSHTEIN PHONE NO : 888 874 7837 437 TURNPIKE ST. SE DECISION MADE: 01-MAR-12 CANTON MA 02021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AONGEN DENTAL COLLAGEN MATRIX AEON ASTRON EUROPE B.V. 510(k) NO: K112568(TRADITIONAL) ATTN: HORNG JI LAI PHONE NO : 317 133 22280 NIELS BOHRWEG 11-13 SE DECISION MADE: 01-MAR-12 LEIDEN NL 2333 CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXMIXING BLOCK MAXTEC, INC. 510(k) NO: K113232(TRADITIONAL) ATTN: TAMMY LAVERY PHONE NO : 801 327 9870 6526 SOUTH COTTONWOOD ST. SE DECISION MADE: 01-MAR-12 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURAD COMPRESSION HOSIERY MEDLINE, INDUSTRIES, INC. 510(k) NO: K112769(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 01-MAR-12 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION 510(k) NO: K112507(TRADITIONAL) ATTN: DIONNE SANDERS PHONE NO : 954 628 0655 2555 DAVIE ROAD SE DECISION MADE: 01-MAR-12 FORT LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER FOOTPRINT MEDICAL INC. 510(k) NO: K120304(SPECIAL) ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN STREET SE DECISION MADE: 01-MAR-12 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: PAIN-AID PDI WORKS, LLC. 510(k) NO: K113037(TRADITIONAL) ATTN: THU-HA DUNCAN PHONE NO : 423 303 9981 2150 SOUTH LEE HIGHWAY SE DECISION MADE: 01-MAR-12 CLEVELAND TN 37311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR HEALTH & LIFE CO., LTD. 510(k) NO: K113238(TRADITIONAL) ATTN: SARAH SU PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-MAR-12 ZHONGHE DISTRICT, NEW TAIPEI TW510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE BIOM'UP SAS 510(k) NO: K103081(TRADITIONAL) ATTN: VALERIE CENTIS PHONE NO : 330 486 573610 8, ALLEE IRENE JOLIOT-CURIE SE DECISION MADE: 02-MAR-12 ST-PRIEST FR 69800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLITAIRE FR REVASCULARIZATION DEVICE MICRO THERAPEUTICS DBA EV3 NEUROVA510(k) NO: K113455(TRADITIONAL) ATTN: LAURA HEATON PHONE NO : 949 837 3700 9775 TOLEDO WAY SE DECISION MADE: 02-MAR-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE VINYL EXAM GLOVE, POWDER FREE FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113797(ABBREVIATED) ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 02-MAR-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: SPEE-DEE PATCH PULPDENT CORPORATION 510(k) NO: K113617(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 Oakland St SE DECISION MADE: 02-MAR-12 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDER PTCA BALLOON CATHETER TRIREME MEDICAL INC 510(k) NO: K111544(TRADITIONAL) ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300 7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 02-MAR-12 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3MP MONOCHROME LCD MONITOR, RADIFORCE GX40 EIZO NANAO CORPORATION 510(k) NO: K113784(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO SE DECISION MADE: 02-MAR-12 IIAKUSAN JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNOTILUS ANCHOR SYSTEM T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K113297(TRADITIONAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVE. SE DECISION MADE: 02-MAR-12 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELICOBACTER PYLORI ELISA IGG TEST KIT GOLD STANDARD DIAGNOSTICS 510(k) NO: K110745(TRADITIONAL) ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000 2851 SPAFFORD SE DECISION MADE: 02-MAR-12 Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS FREEZE (MP)2 SYSTEM VENUS CONCEPT LTD 510(k) NO: K111670(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST SE DECISION MADE: 02-MAR-12 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER HELMET THERADOME INC. 510(k) NO: K113097(TRADITIONAL) ATTN: LARRY PETERSEN PHONE NO : 303 489 2500 1001 BEAR ISLAND RD, SUITE 136 SE DECISION MADE: 02-MAR-12 SUMMERVILLE SC 29483 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER ST. JUDE MEDICAL 510(k) NO: K113584(TRADITIONAL) ATTN: BRYAN COWELL PHONE NO : 978 577 3473 4 ROBBINS ROAD SE DECISION MADE: 02-MAR-12 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-THV SYSTEM PAIEON, INC. 510(k) NO: K113594(TRADITIONAL) ATTN: EREZ BEN-ZVI PHONE NO : 972 391 50000 22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 02-MAR-12 ROSH HAAYIN IS 48901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CARE INFRARED EAR THERMOMETER E-CARE TECHNOLOGY CORPORATION 510(k) NO: K113095(TRADITIONAL) ATTN: KIN-YUAN KO PHONE NO : 866 355 34996 8F-11 NO. 35 HSIN-TAI ROAD SE DECISION MADE: 02-MAR-12 CHUBEI TW 30252 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY AALTO SCIENTIFIC LTD. 510(k) NO: K111964(TRADITIONAL) ATTN: DESSI LYAKOV PHONE NO : 760 431 6942 1959 KELLOGG AVE. SE DECISION MADE: 02-MAR-12 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS 1600 INTRAORAL CAMERA CARESTREAM HEALTH,INC. 510(k) NO: K111423(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 770 226 3287 1765 THE EXCHANGE SE DECISION MADE: 02-MAR-12 ATLANTA GA 30339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) LD TECHNOLOGY LLC 510(k) NO: K113264(TRADITIONAL) ATTN: ABBERT MAAREK PHONE NO : 305 397 9900 100 N. Bicayne Blvd Suite 500 SE DECISION MADE: 02-MAR-12 Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELTAMAXX 18 MICROCOIL SYSTEM CODMAN AND SHURTLEFF, INC. 510(k) NO: K120274(SPECIAL) ATTN: KIM FONDA PHONE NO : 408 433 1420 325 PARAMOUNT DR. SE DECISION MADE: 02-MAR-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113750(ABBREVIATED) ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 05-MAR-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: VIRTUOSO SYSTEM FOR IHC PR (IE2) VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K111869(TRADITIONAL) ATTN: TROY QUANDER PHONE NO : 520 229 4184 1910 EAST INNOVATION PARK DR. SE DECISION MADE: 05-MAR-12 TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-MAX X TURBINE NAKANISHI, INC. 510(k) NO: K113655(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 05-MAR-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLIF CAGE EISERTECH, LLC 510(k) NO: K113478(ABBREVIATED) ATTN: LUKAS EISERMANN PHONE NO : 888 262 2817 2555 FRONT STREET SE DECISION MADE: 05-MAR-12 SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMBIQ INFUSION AND ADMINSTRATION SET HOSPIRA, INC. 510(k) NO: K110901(TRADITIONAL) ATTN: RAY SILKAITIS PHONE NO : 224 212 4897 275 NORTH FIELD DR. SE DECISION MADE: 05-MAR-12 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K111792(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 05-MAR-12 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE TERUMO (PHILIPPINES) CORPORATION 510(k) NO: K113422(SPECIAL) ATTN: SANDI HARTKA PHONE NO : 410 392 7241 #124 EAST MAIN AVE. LAGUNA TECHNOPSE DECISION MADE: 05-MAR-12 BINAN, LAGUNA RP 4026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIME-LITE II PULPDENT CORPORATION 510(k) NO: K113711(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 Oakland St SE DECISION MADE: 05-MAR-12 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE 510(k) NO: K111268(TRADITIONAL) ATTN: WEIPING ZHONG PHONE NO : 574 257 3075 430 SOUTH BEIGER STREET SE DECISION MADE: 06-MAR-12 MISHAWAKA IN 46544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE VINYL EXAM GLOVE, POWDERED FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113790(ABBREVIATED) ATTN: ELIZABTEH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 06-MAR-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED MAYER LABORATORIES, INC. 510(k) NO: K113686(ABBREVIATED) ATTN: DAVID P MAYER PHONE NO : 510 229 5300 1950 ADDISON STREET, SUITE 101 SE DECISION MADE: 06-MAR-12 BERKELY CA 94704 1182 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVATOR V-E ACTIVATOR METHODS INTERNATIONAL LT510(k) NO: K112606(TRADITIONAL) ATTN: ARLAN W FUHR PHONE NO : 602 224 0220 2950 N. SEVENTH ST. SE DECISION MADE: 06-MAR-12 PHOENIX AZ 85014 510(k) STATEMENT DEVICE: NEO NEST DENOVO PROUCTS LLC 510(k) NO: K112547(TRADITIONAL) ATTN: DALE WALTERS PHONE NO : 239 245 7030 17051 ALICO COMMERCE CT. #3 SE DECISION MADE: 06-MAR-12 FT. MYERS FL 33967 510(k) STATEMENT DEVICE: FORESIGHT U120 URINE ANALYZER ACON LABORATORIES, INC. 510(k) NO: K120124(SPECIAL) ATTN: QIYI XIE PHONE NO : 858 875 8011 10125 Mesa Rim Road SE DECISION MADE: 06-MAR-12 SAN DIEGO CA 92121 510(k) STATEMENT DEVICE: SONICEYE ULTRASOUND TRANSDUCER BLACKTOE MEDICAL III, INC. 510(k) NO: K113832(ABBREVIATED) ATTN: KENDRA RATHKEY PHONE NO : 503 476 7049 8305 CREEKSIDE PLACE SUITE C SE DECISION MADE: 06-MAR-12 BEAVERTON OR 97008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERASAGE HEATING PAD THERASAGE CORPORATION 510(k) NO: K120254(TRADITIONAL) ATTN: ROBERT BESNER PHONE NO : 888 416 4441 21000 Boca Rio Road, Suite A21-C SE DECISION MADE: 06-MAR-12 BOCA RATON FL 33433 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HONGXIN PLASTIC PRODUCTS CO., LTD 510(k) NO: K120358(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BUILDING, 1 JIAN XIANG YUASE DECISION MADE: 06-MAR-12 ROAD HAI DI, BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC TREK OTW CORONARY DILATATION CATHETER ABBOTT VASCULAR 510(k) NO: K113464(TRADITIONAL) ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243 26531 YNEZ ROAD P.O. BOX 9018 SE DECISION MADE: 06-MAR-12 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLOGIC VISCERAL FAT SOFTWARE HOLOGIC, INC. 510(k) NO: K113356(TRADITIONAL) ATTN: EILEEN M BOYLE PHONE NO : 781 999 7781 35 CROSBY DR. SE DECISION MADE: 06-MAR-12 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT ULTRA PK SUTURE ANCHOR SMITH & NEPHEW, INC. 510(k) NO: K113274(TRADITIONAL) ATTN: MELISSA EGAN PHONE NO : 508 261 3645 150 MINUTEMAN RD. SE DECISION MADE: 06-MAR-12 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVI ERGON-X HF VIVI S.R.L. 510(k) NO: K120318(TRADITIONAL) ATTN: GUIDO BONAPACE PHONE NO : 390 542 683903 VIA BORGO SANTA CRISTINA ,12 SE DECISION MADE: 06-MAR-12 IMOLA IT 40026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K120505(SPECIAL) ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 06-MAR-12 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY POSITIONER FUJI FILM MEDICAL SYSTEMS 510(k) NO: K113284(TRADITIONAL) ATTN: KIMERLY A SHARP PHONE NO : 203 602 3665 419 WEST AVE. SE DECISION MADE: 07-MAR-12 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXERYL CREAM PIERRE FABRE MEDICAL DEVICES 510(k) NO: K113807(TRADITIONAL) ATTN: DIANE MANDELL HORWITZ PHONE NO : 703 307 2921 1129 TWENTIETH ST., NW SUITE 600 SE DECISION MADE: 07-MAR-12 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUREGRAFT 850/PURE SYSTEM CYTORI THERAPEUTICS, INC. 510(k) NO: K113255(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858 458 0900 3020 CALLAN ROAD SE DECISION MADE: 07-MAR-12 SAN DIEGO CA 92121 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVANT, MOBILC CARDIAC TELEMETRY CORVENTIS, INC. 510(k) NO: K113372(SPECIAL) ATTN: KATHLEEN LUNDBERG PHONE NO : 651 925 3807 1410 ENERGY PARK DRIVE SUITE 1 SE DECISION MADE: 07-MAR-12 Saint Paul MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HILLA DIGITAL TRANSFERS HILLA TECHNOLOGIES, INC. 510(k) NO: K113575(TRADITIONAL) ATTN: CAROLYN M PRIMUS PHONE NO : 941 753 9737 7046 OWL'S NEST TERRACE SE DECISION MADE: 07-MAR-12 BRADENTON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER SEAL TOOTH DESENSITIZER PHOENIX DENTAL, INC. 510(k) NO: K120109(TRADITIONAL) ATTN: JEFFREY S COX PHONE NO : 810 750 2328 3452 WEST THOMPSON RD. SE DECISION MADE: 07-MAR-12 FENTON MI 48430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM PHYGEN, LLC 510(k) NO: K120355(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 949 752 7885 2301 Dupont Drive, Suite 510 SE DECISION MADE: 07-MAR-12 Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOVISION PERIDOT TECHNOLOGIES NY INC 510(k) NO: K113082(TRADITIONAL) ATTN: OMAR BARLAS PHONE NO : 718 424 0633 9131 QUEENS BLVD. SUITE U SE DECISION MADE: 08-MAR-12 ELMHURST NY 11373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFS LASER SYSTEM ABBOTT MEDICAL OPTICS INC 510(k) NO: K113151(TRADITIONAL) ATTN: KESLEY E GALLAGHER PHONE NO : 714 247 8930 1700 EAST SAINT ANDREW PL SE DECISION MADE: 08-MAR-12 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER ADAPTOR INSTRUMENT ACCESSORY STRYKER CORP. 510(k) NO: K120434(SPECIAL) ATTN: TIFFANI ROGERS PHONE NO : 201 760 8206 2 PEARL COURT SE DECISION MADE: 08-MAR-12 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADRASPHERE 30 TO 60 BIOSPHERE MEDICAL, INC. 510(k) NO: K113822(SPECIAL) ATTN: LINDA J VARROSO PHONE NO : 781 681 7900 1050 HINGHAM ST. SE DECISION MADE: 08-MAR-12 ROCKLAND MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES ALMA LASERS INC. 510(k) NO: K113810(TRADITIONAL) ATTN: TATIANA EPSTEIN PHONE NO : 925 895 1200 485 HALF DAY RD. SUITW NO. 100 SE DECISION MADE: 08-MAR-12 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE VIDACARE CORPORATION 510(k) NO: K113872(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 08-MAR-12 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIASYS 450 AMS 510(k) NO: K113131(TRADITIONAL) ATTN: STEFANO CORRADI PHONE NO : 390 774 3544 17/A VIA E. BARSANTI SE DECISION MADE: 08-MAR-12 GUIDONIA, ROME IT I-00012 510(k) STATEMENT DEVICE: ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED ARTHREX, INC. 510(k) NO: K120044(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 08-MAR-12 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR JIANGSU YUYUE MEDICAL EQUIPMENT & 510(k) NO: K120526(TRADITIONAL) ATTN: NED DEVINE PHONE NO : 333 PFINGSTEN ROAD SE DECISION MADE: 08-MAR-12 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICT TSH MAGNABIOSCIENCES, LLC 510(k) NO: K110761(TRADITIONAL) ATTN: JAMES L WYATT PHONE NO : 858 481 4400 6325 LUSK BLVD SE DECISION MADE: 09-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCEND SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K113413(SPECIAL) ATTN: BRAHIM HADRI PHONE NO : 781 249 8030 7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 09-MAR-12 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL FIXATION SYSTEM LANX, LLC 510(k) NO: K120399(SPECIAL) ATTN: MICHAEL FUNK PHONE NO : 303 443 7500 310 INTERLOCKEN PARKWAY STE 120 SE DECISION MADE: 09-MAR-12 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMO-CATH 10F, HEMO-CATH 12.5F MEDICAL COMPONENTS INC 510(k) NO: K113487(SPECIAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 09-MAR-12 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIPELINE TOTAL HIP SYSTEM PIPELINE ORTHOPEDICS 510(k) NO: K112802(TRADITIONAL) ATTN: TERRY POWELL PHONE NO : 703 562 9800 901 KING STREET, SUITE 200 SE DECISION MADE: 09-MAR-12 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRONY RESPIRATORY TRACKING SYSTEM ACCURAY INCORPORATED 510(k) NO: K120233(TRADITIONAL) ATTN: ANNE SCHLAGENHAFT PHONE NO : 408 716 4600 1310 CHESAPEAKE TERRACE SE DECISION MADE: 09-MAR-12 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS NOVA BIOMEDICAL CORPORATION 510(k) NO: K112638(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781 894 0800 200 Prospect St SE DECISION MADE: 09-MAR-12 WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE KIMBERLY-CLARK CORP. 510(k) NO: K113423(TRADITIONAL) ATTN: LESTER F PADILLA PHONE NO : 678 352 6766 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 09-MAR-12 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HBIDB - HUMAN BRIAN INDEX SOFTWARE CORSCIENCE GMBH & CO. KG 510(k) NO: K112077(TRADITIONAL) ATTN: PATRIK R KAREM PHONE NO : 412 372 8571 700-706 SECO RD SE DECISION MADE: 09-MAR-12 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL RETRACTORS SURGICAL INNOVATIONS PLC 510(k) NO: K112659(TRADITIONAL) ATTN: STEPHEN SEED PHONE NO : 440 113 2307597 CLAYTON WOOD HOUSE, 6 CLAYTON WOODSE DECISION MADE: 09-MAR-12 LEEDS, WEST YORKSHIRE UK LS16 6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CONCENTIRC MICROCATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K113260(SPECIAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 09-MAR-12 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATURN 8000 NEW MEDICAL CO., LTD. 510(k) NO: K120380(TRADITIONAL) ATTN: JUN-HSIUNG LIN PHONE NO : 909 244 6562 1441 KEM WAY SE DECISION MADE: 09-MAR-12 WALNUT CA 91789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QLAB QUANTIFICATION SOFTWARE PHILIPS HEALTHCARE GROUP 510(k) NO: K120525(SPECIAL) ATTN: PENNY GRECO PHONE NO : 978 659 4615 3000 MINUTEMAN ROAD SE DECISION MADE: 09-MAR-12 ANDOVER MA 01810 7324 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADAPTIVE WEDGE ADAPTIVE SPECIALTY, LLC 510(k) NO: K110662(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 590 5810 1001 OAKWOOD BLVD SE DECISION MADE: 12-MAR-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE LUMBAR IBF SYSTEM RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K113540(TRADITIONAL) ATTN: BRET M BERRY PHONE NO : 801 718 7467 545 SOUTH 500 WEST SUITE 100 SE DECISION MADE: 12-MAR-12 BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K113624(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE SUITE F SE DECISION MADE: 12-MAR-12 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILDCAT CATHETER AVINGER, INC. 510(k) NO: K113838(TRADITIONAL) ATTN: SEVRINA CIUCCI PHONE NO : 650 241 7900 400 CHESAPEAKE DRIVE SE DECISION MADE: 12-MAR-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. 510(k) NO: K113860(TRADITIONAL) ATTN: AMY MCKINNEY PHONE NO : 651 287 5096 63 CHICORY CT. SE DECISION MADE: 12-MAR-12 LAKE JACKSON TX 77566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAUMA INTERNAL FIXATION SYSTEMS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K111663(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-MAR-12 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER POSTERIOR CERVICO THORACIC SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K112757(SPECIAL) ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 12-MAR-12 MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER NIPRO MEDICAL CORPORATION 510(k) NO: K113429(SPECIAL) ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 12-MAR-12 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL ENHATCH ORTHOPAEDICS LLC 510(k) NO: K112663(TRADITIONAL) ATTN: MICHAEL PHIPPS PHONE NO : 201 377 9129 1050 WALL ST WEST SUITE 340 SE DECISION MADE: 12-MAR-12 LYNDHURST NJ 07071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. 510(k) NO: K103116(SPECIAL) ATTN: STEVEN SHEN PHONE NO : 886 282 272188 7F, NO 186, JIAN-YI ROAD SE DECISION MADE: 13-MAR-12 JUNG-HE, TAIPEI COUNTY TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION DELBIO INCORPORATION 510(k) NO: K103329(TRADITIONAL) ATTN: NICKY PAN PHONE NO : 886 3 3591968 252, SHANGYING ROAD GUISHAN INDUSTSE DECISION MADE: 13-MAR-12 TAOYUAN COUNTY TW 33341 510(k) STATEMENT DEVICE: MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K113688(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 13-MAR-12 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS TORNIER 510(k) NO: K112144(SPECIAL) ATTN: SEVERINE BONNETON PHONE NO : 003 347 6613500 161 RUE LAVOISIER SE DECISION MADE: 13-MAR-12 MONTBONNOT, SAINT-ISMIER FR 383510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE COROENT NO-PROFILE SYSTEM NUVASIVE, INC. 510(k) NO: K112561(SPECIAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 13-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOCOOL (TM) RF ABLATION SYSTEM BAYLIS MEDICAL CO., INC. 510(k) NO: K111523(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 13-MAR-12 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VETA PERITONEAL DIALYSIS CATHETER PFM MEDICAL, INC 510(k) NO: K113354(TRADITIONAL) ATTN: SALVADORE PALOMARES PHONE NO : 760 758 8749 1815 Aston Ave Suite 106 SE DECISION MADE: 13-MAR-12 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE 510(k) NO: K113157(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 Hassell Rd Ste 1535 SE DECISION MADE: 13-MAR-12 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASFORA BULLET CAGE MEDICAL DESIGNS, LLC 510(k) NO: K112648(SPECIAL) ATTN: KRISTI VONDRA PHONE NO : 605 275 1032 1210 W. 18TH ST. SUITE 104 SE DECISION MADE: 13-MAR-12 SIOUX FALLS SD 57104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K102189(TRADITIONAL) ATTN: NEIL BURRIS PHONE NO : 303 832 8200 11925 W 1-70 FRONTAGE RD NORTH, SUSE DECISION MADE: 14-MAR-12 WHEAT RIDGE CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOUNDATION SPINAL SYSTEM THE SKELETAL DESIGN PARTNERSHIP LT510(k) NO: K120074(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 14-MAR-12 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIAVALVE SAFETY IV CATHETER SMITHS MEDICAL ASD, INC. 510(k) NO: K113700(TRADITIONAL) ATTN: BRIAN FARIAS PHONE NO : 603 352 3812 201 WEST QUEEN ST. SE DECISION MADE: 14-MAR-12 SOUTHINGTON CT 06489 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENFLOW IV FLUID WARMER VITAL SIGNS, INC. 510(k) NO: K112902(TRADITIONAL) ATTN: STACIE GEFFNER-ATIYA PHONE NO : 973 956 5491 20 CAMPUS RD. SE DECISION MADE: 14-MAR-12 TOTOWA NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE BM KOREA CO., LTD. 510(k) NO: K111820(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 14-MAR-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC. 510(k) NO: K120439(SPECIAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 5500 EAST 2ND ST. SE DECISION MADE: 14-MAR-12 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA ENCORE MEDICAL, L.P. 510(k) NO: K113756(SPECIAL) ATTN: TEFFANY HUTTO PHONE NO : 512 832 9500 9800 METRIC BLVD. SE DECISION MADE: 14-MAR-12 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR-BAG SYSTEM NIIGATA MECHATRONICS CO., LTD. 510(k) NO: K112969(TRADITIONAL) ATTN: TOSHIYA NIMONJI PHONE NO : 81 252 553932 3268-18, SHIMAMI-CHO, KITA-KU SE DECISION MADE: 14-MAR-12 NIIGATA-CITY JA 950-3102 510(k) STATEMENT DEVICE: ORTHOSIZE ORTHOSIZE LLC 510(k) NO: K120115(TRADITIONAL) ATTN: YARMELA PAVLOVIC PHONE NO : 267 675 4618 1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 14-MAR-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-GENIN, R-GENIN BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K113791(TRADITIONAL) ATTN: FRANCOIS GENIN PHONE NO : 510 883 0500 901 GRAYSON ST., SUITE 101 SE DECISION MADE: 15-MAR-12 Berkeley CA 94710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113749(ABBREVIATED) ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 15-MAR-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: QUIDEL MOLECULAR INFLUENZA A+B QUIDEL CORP. 510(k) NO: K113777(TRADITIONAL) ATTN: RONALD H LOLLAR PHONE NO : 858 552 1100 10165 MCKELLAR CT. SE DECISION MADE: 15-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CITIEFFE TITANIUM NAILING SYSTEM CITIEFFE 510(k) NO: K113387(TRADITIONAL) ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630 110 E. GRANADA BLVD. SUITE 209 SE DECISION MADE: 15-MAR-12 ORMOND BEACH FL 32176 510(k) STATEMENT DEVICE: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH AGA MEDICAL CORPORATION 510(k) NO: K120120(SPECIAL) ATTN: RASHMI BHUSHAN PHONE NO : 651 756 5767 5050 NATHAN LANE SE DECISION MADE: 15-MAR-12 PLYMOUTH MN 55433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREFUSION NICOLET EDX CAREFUSION 209, INC. 510(k) NO: K112052(TRADITIONAL) ATTN: ROBERT BURDGE PHONE NO : 608 829 8655 1850 Deming Way SE DECISION MADE: 15-MAR-12 Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IM-11 PNEUMATIC MICROINJECTOR NARISHIGE CO., LTD. 510(k) NO: K113712(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 15-MAR-12 SETAGAYA-KU, TOKYO JA 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 COVIDIEN 510(k) NO: K111933(TRADITIONAL) ATTN: JEAN SIMON PHONE NO : 303 305 2435 6135 GUNBARREL AVE. SE DECISION MADE: 15-MAR-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCENTRIC BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K112404(TRADITIONAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 15-MAR-12 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LEVEEN SUPERSLIM NEEDLE ELECTRODE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K113090(TRADITIONAL) ATTN: ASHLEY PYLE PHONE NO : 508 683 4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 15-MAR-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 ZOLL CIRCULATION 510(k) NO: K112998(TRADITIONAL) ATTN: SAM NANAVATI PHONE NO : 408 419 2950 650 Almanor Ave SE DECISION MADE: 15-MAR-12 Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC APPLICATOR MICROMEDICS, INC. 510(k) NO: K120608(TRADITIONAL) ATTN: LISE W DURAN PHONE NO : 651 452 1977 1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 15-MAR-12 ST. PAUL MN 55121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONQUEST 40 PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K120660(TRADITIONAL) ATTN: ASHLEY FICKETT PHONE NO : 480 300 2664 1625 WEST 3RD ST. SE DECISION MADE: 15-MAR-12 TEMPE AZ 85280 1740 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014") TRIREME MEDICAL INC 510(k) NO: K120677(SPECIAL) ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300 7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 15-MAR-12 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UNIVERSAL MAXILLARY MOLAR OCO BIOMEDICAL 510(k) NO: K110337(TRADITIONAL) ATTN: JACK BLOOM PHONE NO : 505 293 0025 8500 WASHINGTON ST. NE SUITE A-1 SE DECISION MADE: 16-MAR-12 ALBUQUERQUE NM 87113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE NVM5 SYSTEM NUVASIVE, INC. 510(k) NO: K112718(TRADITIONAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 16-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFLEX ACRILATO NUXEN S.R.L. 510(k) NO: K113788(TRADITIONAL) ATTN: HERNAN ILARI PHONE NO : 541 146 446966 J B JUSTO 9741, PB SE DECISION MADE: 16-MAR-12 BUENOS AIRES AR C1408ALB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM C.R. BARD INC., BARD ELECTROPHYSIO510(k) NO: K113811(TRADITIONAL) ATTN: ANASTASIA C RANDALL PHONE NO : 978 323 2348 55 TECHNOLOGY DR. SE DECISION MADE: 16-MAR-12 LOWELL MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON CARDIOLOGY ECG MANAGEMENT MCKESSON ISRAEL LTD. 510(k) NO: K113515(TRADITIONAL) ATTN: TOMER LEVY PHONE NO : 972 376 8000 HANECHOSHET 4 SE DECISION MADE: 16-MAR-12 TEL AVIV IS 69710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE NOBLES MEDICAL TECHNOLOGIES II, IN510(k) NO: K113763(SPECIAL) ATTN: MARIA HATEGAN PHONE NO : 714 427 0398 17080 Newhope St SE DECISION MADE: 16-MAR-12 Fountain Valley CA 92708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K113766(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 16-MAR-12 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T GEM FLEX COIL NEOCOIL, LLC 510(k) NO: K113474(ABBREVIATED) ATTN: STEVEN NICHOLS PHONE NO : 262 347 1250 N27 W23910A PAUL RD. SE DECISION MADE: 16-MAR-12 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE(R) EMBOLIC FILTER W.L. GORE & ASSOCIATES 510(k) NO: K120480(SPECIAL) ATTN: MICHELLE ANN WELLS PHONE NO : 800 437 8181 4250 WEST KILTIE LN SE DECISION MADE: 16-MAR-12 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 EXACTECH, INC. 510(k) NO: K113320(SPECIAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 16-MAR-12 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHESAPEAKE SPINAL SYSTEM K2M, INC. 510(k) NO: K120031(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 16-MAR-12 Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P NIHON KOHDEN AMERICA, INC. 510(k) NO: K120485(SPECIAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON ST. SE DECISION MADE: 16-MAR-12 FOOTHILL RANCH CA 92610 1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 9 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K120060(TRADITIONAL) ATTN: YUCHI CHU PHONE NO : 425 949 4907 10604 NE 38TH PLACE SUITE 229 SE DECISION MADE: 16-MAR-12 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSORB ABSORBALBE STAPLE INCISIVE SURGICAL, INC. 510(k) NO: K120373(SPECIAL) ATTN: DAVID HERRIDGE PHONE NO : 952 591 2543 14405 21ST AVE N. SUITE 130 SE DECISION MADE: 16-MAR-12 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO-EXPRESS (R) HANDPIECE ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K111541(TRADITIONAL) ATTN: JEFFREY WAN PHONE NO : 201 487 9090 89 LEUNING STREET SUITE 8 SE DECISION MADE: 16-MAR-12 SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMTO LDV SIE AG,SURGICAL INSTUMENT ENGINEER510(k) NO: K112154(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 16-MAR-12 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: RNARETAIN ASURAGEN, INC. 510(k) NO: K113420(TRADITIONAL) ATTN: LUC VAN HOVE PHONE NO : 512 681 5200 2150 WOODWARD ST. SUITE 100 SE DECISION MADE: 16-MAR-12 AUSTIN TX 78744 1840 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROCARDIOGRAPH EDAN INSTRUMENTS INC 510(k) NO: K120188(SPECIAL) ATTN: YUE QIUHONG PHONE NO : 867 552 6899197 3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 16-MAR-12 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) HEALTH & LIFE CO., LTD. 510(k) NO: K113239(TRADITIONAL) ATTN: SARAH SU PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 16-MAR-12 ZHONGHE DISTRICT, NEW TAIPEI TW510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD BACTEC PLUS AEROBIC/F (PLASTIC) BECTON, DICKINSON AND COMPANY 510(k) NO: K113558(TRADITIONAL) ATTN: PAUL SWIFT PHONE NO : 410 316 4905 7 LOVETON CIRCLE MC 614 SE DECISION MADE: 16-MAR-12 SPARKS MD 21043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO TENGYUE PLASTIC PRODUCTS CO.,510(k) NO: K110536(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVENUE SE DECISION MADE: 19-MAR-12 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K112682(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 19-MAR-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. BARD, INC. 510(k) NO: K113808(TRADITIONAL) ATTN: HENRY BOLAND PHONE NO : 801 595 0700 605 NORTH 5600 WEST SE DECISION MADE: 19-MAR-12 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILTEK BULK FILL FLOWABLE RESTORATIVE 3M ESPE DENTAL PRODUCTS 510(k) NO: K120453(TRADITIONAL) ATTN: SCOTT ERICKSON PHONE NO : 651 736 9883 3M CENTER; BLDG 260-2A-11 SE DECISION MADE: 19-MAR-12 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLEURX PERITONEAL CATHETER SYSTEM CAREFUSION 510(k) NO: K113854(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7407 1500 WAUKEGAN ROAD SE DECISION MADE: 19-MAR-12 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODAN SAFEFEED ENTERAL FEEDING RESERVOIR CODAN US CORP. 510(k) NO: K112268(TRADITIONAL) ATTN: JEFF NIELSEN PHONE NO : 714 430 1303 3511 WEST SUNFLOWER AVE. SE DECISION MADE: 19-MAR-12 SANTA ANA CA 92704 6944 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: HIVOX BIOTEK INC. HIVOX BIOTEK, INC. 510(k) NO: K112392(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 19-MAR-12 HSIN-CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) MARUCHI 510(k) NO: K112078(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 19-MAR-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARCORRECT SYSTEM CLEARCORRECT, INC. 510(k) NO: K113618(TRADITIONAL) ATTN: CHERYL FISHER PHONE NO : 408 410 5920 611 W. 5TH STREET THIRD FLOOR SE DECISION MADE: 19-MAR-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL90 FLEX RADIOMETER MEDICAL APS 510(k) NO: K120197(SPECIAL) ATTN: MARTIN GABLER PHONE NO : 453 827 3114 AAKANDEVEJ 21 SE DECISION MADE: 19-MAR-12 BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN ST. JUDE MEDICAL 510(k) NO: K120544(SPECIAL) ATTN: MARLENE PETERSON PHONE NO : 651 756 5162 14901 DEVEAU PL. SE DECISION MADE: 19-MAR-12 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 BIOMET SPINE & BONE HEALING TECHNO510(k) NO: K120557(SPECIAL) ATTN: MARGARET F CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 19-MAR-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWDEAL INTERPHALANGEAL IMPLANT NEWDEAL SAS 510(k) NO: K103623(TRADITIONAL) ATTN: MARILYSE LATOUR PHONE NO : 334 374 75168 IMMEUBLE SEQUOIA 2, 97 ALLEE ALEXASE DECISION MADE: 20-MAR-12 PARC TECHNOLOGIQUE DE LA PRTE F510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V1 SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K111756(TRADITIONAL) ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 20-MAR-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIPELINE CR PRIMARY KNEE SYSTEM PIPELINE ORTHOPEDICS 510(k) NO: K113122(TRADITIONAL) ATTN: TERRY POWELL PHONE NO : 703 562 9800 901 KING STREET, SUITE 200 SE DECISION MADE: 20-MAR-12 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K112100(TRADITIONAL) ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 20-MAR-12 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K113475(TRADITIONAL) ATTN: TAMER IBRAHIM PHONE NO : 925 543 2110 2603 CAMINO RAMON SUITE 100 SE DECISION MADE: 20-MAR-12 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOTOME ELITE BIOPSY SYSTEM DEVICOR MEDICAL PRODUCTS INC. 510(k) NO: K112411(TRADITIONAL) ATTN: SHAWNA M ROSE PHONE NO : 513 864 9178 300 E. BUSINESS WAY FIFTH FLOOR SE DECISION MADE: 20-MAR-12 CINCINNATI OH 45241 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO RT INTERFACE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K120363(TRADITIONAL) ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157 4040 NELSON AVE. SE DECISION MADE: 20-MAR-12 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOBOLT ARTHREX, INC. 510(k) NO: K120540(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 20-MAR-12 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM HEI, INC. 510(k) NO: K102900(TRADITIONAL) ATTN: GREGORY MATHISON PHONE NO : 218 387 1559 4801 NORTH 63RD. ST. SE DECISION MADE: 21-MAR-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAUTERINE INSEMINATION (IUI) CATHETER CATHETER RESEARCH, INC. 510(k) NO: K120154(ABBREVIATED) ATTN: BABACAR DIOUF PHONE NO : 317 872 0074 5610 W 82nd St SE DECISION MADE: 21-MAR-12 INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL PULPDENT CORPORATION 510(k) NO: K113818(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 Oakland St SE DECISION MADE: 21-MAR-12 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR UPSTREAM PERIPHERAL TECHNOLOGIES 510(k) NO: K112887(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 21-MAR-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSEY BED J. T. POSEY CO. 510(k) NO: K113357(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 626 454 2195 5635 PECK RD. SE DECISION MADE: 21-MAR-12 ARCADIA CA 91006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULTOL SHARP CORPORATION 510(k) NO: K113865(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 21-MAR-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) UG HEALTHCARE (USA), INC. 510(k) NO: K112005(TRADITIONAL) ATTN: KEN STANTON PHONE NO : 714 444 2248 1656 SUNFLOWER AVE. SE DECISION MADE: 21-MAR-12 COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES UG HEALTHCARE (USA), INC. 510(k) NO: K112012(TRADITIONAL) ATTN: KEN STANTON PHONE NO : 714 444 2248 1565 SUNFLOWER AVE. SE DECISION MADE: 21-MAR-12 COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL X SERIES ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K112432(TRADITIONAL) ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 21-MAR-12 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM SYNTHES USA 510(k) NO: K120070(TRADITIONAL) ATTN: ANGELA F LASSANDRO PHONE NO : 610 719 6854 1301 GOSHEN PKWY SE DECISION MADE: 21-MAR-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOLOGICAL MONITOR, PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K113441(TRADITIONAL) ATTN: JENS-PETER SEHER PHONE NO : 497 031 4632086 HEWLETT-PACKARD STR.2 SE DECISION MADE: 22-MAR-12 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K113798(TRADITIONAL) ATTN: BETH A ZIS PHONE NO : 978 379 8265 6 TECH DRIVE SE DECISION MADE: 22-MAR-12 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE PATIENT MONITOR PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K113657(TRADITIONAL) ATTN: MANFRED STEVER PHONE NO : 497 031 4632186 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 22-MAR-12 BOBLINGEN GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) BOSTON SCIENTIFIC CORPORATION 510(k) NO: K113220(TRADITIONAL) ATTN: VICKY L HAGENS PHONE NO : 763 255 0303 ONE SCIMED PLACE SE DECISION MADE: 22-MAR-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISI MOBILE MONITORING SYSTEM SOTERA WIRELESS, INC 510(k) NO: K112478(TRADITIONAL) ATTN: EBEN GORDON PHONE NO : 858 373 4841 9444 WAPLES STREET SE DECISION MADE: 22-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS ARKON ANESTHESIA WORKSTATION SPACELABS HEALTHCARE 510(k) NO: K113051(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 P.O. BOX 3018 SE DECISION MADE: 22-MAR-12 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC. 510(k) NO: K111702(TRADITIONAL) ATTN: KIM FORCH PHONE NO : 847 550 7909 THREE CORPORATE DRIVE SE DECISION MADE: 22-MAR-12 LAKE ZURICH IL 60047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZSLEEP SLEEP QUALITY RECORDER PLATINUM TEAM CO., LTD 510(k) NO: K112573(TRADITIONAL) ATTN: JAMES HO PHONE NO : 886 228 968019 396 DAYE ROAD SE DECISION MADE: 22-MAR-12 TAIPAI TW 11268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENII GI 4000 ELECTROSUGICAL GENERATOR GENII, INC. 510(k) NO: K113265(TRADITIONAL) ATTN: JULIE POWELL PHONE NO : 512 327 9997 611 WEST 5TH FLOOR THIRD FLOOR SE DECISION MADE: 22-MAR-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX NIHON KOHDEN AMERICA, INC. 510(k) NO: K113117(SPECIAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON ST. SE DECISION MADE: 22-MAR-12 FOOTHILL RANCH CA 92610 1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLIS 12I TOKYO BOEKI MEDISYS INC. 510(k) NO: K110520(TRADITIONAL) ATTN: JAMES M CLINTON PHONE NO : 919 247 0479 5105 FAIROAKS ROAD SE DECISION MADE: 23-MAR-12 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP ZEPHYR SLEEP TECHNOLOGIES INC 510(k) NO: K103704(ABBREVIATED) ATTN: SABINA BRUCHLMANN PHONE NO : 403 210 6824 2513 17 ST SE SE DECISION MADE: 23-MAR-12 CALGARY; ALBERTA CA T2L 2K7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) IMRIS, INC. 510(k) NO: K113748(TRADITIONAL) ATTN: SANJAY SHAH PHONE NO : 204 480 7070 100-1370 SONY PLACE SE DECISION MADE: 23-MAR-12 WINNIPEG, MB CA R3T 1N5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K112377(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-MAR-12 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY 510(k) NO: K120049(TRADITIONAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 23-MAR-12 SAN DIEGO CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM SONOWAND AS 510(k) NO: K112469(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRANCE NE SE DECISION MADE: 23-MAR-12 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLADDER SCANNER MEDA CO. LTD. 510(k) NO: K113304(TRADITIONAL) ATTN: KAI CHEN PHONE NO : 240 888 4001 13505 BROADFIELD DR. SE DECISION MADE: 23-MAR-12 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC 510(k) NO: K113866(TRADITIONAL) ATTN: KENNETH B HERLAND PHONE NO : 651 429 7413 1290 HAMMOND RD. SE DECISION MADE: 23-MAR-12 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESORB X-G KLS-MARTIN L.P. 510(k) NO: K112064(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904 641 7746 11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 23-MAR-12 JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-LIPO SYSTEM CHROMOGENEX TECHNOLOGIES LIMITED 510(k) NO: K111501(TRADITIONAL) ATTN: PETER R BEVAN PHONE NO : 44 155 4755444 UNITS 1& 2 HEOL RHOSYN PARC DAFEN SE DECISION MADE: 23-MAR-12 LLANELLI, CARMARTHENSHIRE UK SA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K113733(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 23-MAR-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECULUM, VAGINAL, NONMETAL WELCH ALLYN, INC. 510(k) NO: K120743(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. PO BOX 220 SE DECISION MADE: 23-MAR-12 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE CONTROL UNIT HOLOGIC, INC. 510(k) NO: K120593(SPECIAL) ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857 250 CAMPUS DRIVE SE DECISION MADE: 23-MAR-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APACERAM BONE GRAFT SUBSTITUTE HOYA CORPORATION 510(k) NO: K120602(SPECIAL) ATTN: PATSY J TRISLER PHONE NO : 301 652 5344 5600 WISCONSIN AVENUE #509 SE DECISION MADE: 23-MAR-12 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALLS M SPINAL SYSTEM KOREA BONE BANK CO., LTD 510(k) NO: K120538(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST UNIT B SE DECISION MADE: 23-MAR-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION CAREFUSION 303,INC. 510(k) NO: K110535(TRADITIONAL) ATTN: GABRIELA MURANEVICI PHONE NO : 858 617 5889 10020 PACIFIC MESA BLVD SE DECISION MADE: 26-MAR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS SPINAL FIXATION SYSTEM L&K BIOMED CO., LTD 510(k) NO: K120270(TRADITIONAL) ATTN: HEE KYEONG JOO PHONE NO : 822 262 41475 #1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 26-MAR-12 GEUMCHEON-GU, SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC. 510(k) NO: K120572(SPECIAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 5500 EAST 2ND ST. SE DECISION MADE: 26-MAR-12 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOUND PROTECTOR COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K120061(TRADITIONAL) ATTN: JOSEPH CANAVAN PHONE NO : 203 492 8032 60 Middletown Ave SE DECISION MADE: 27-MAR-12 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) ALCON RESEARCH, LTD. 510(k) NO: K112977(ABBREVIATED) ATTN: CATHERINE GOBLE PHONE NO : 817 551 6816 6201 SOUTH FREEWAY SE DECISION MADE: 27-MAR-12 FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K113672(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 27-MAR-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIFIX P KNOTLESS FIXATION DEVICE ARTHROCARE CORPORATION 510(k) NO: K120096(TRADITIONAL) ATTN: CHERYL FREDERICK PHONE NO : 512 391 5751 7000 West William Cannon Drive BLDSE DECISION MADE: 27-MAR-12 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANESTHESIA INJECTION TOOL SET KI WORKS CO., LTD. 510(k) NO: K113247(TRADITIONAL) ATTN: EILEEN YANG PHONE NO : 824 247 62977 MIGUN TECHNOWOLRD 2 C-DONG 524 #53SE DECISION MADE: 27-MAR-12 YONGSAN-DONG, DAEJEON KS KS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIA ONCOLOGY MEVIS MEDICAL SOLUTIONS AG 510(k) NO: K120484(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 262 691 9530 N27 W24075 PAUL COURT SUITE 100 SE DECISION MADE: 27-MAR-12 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESSCAN RESMED LTD. 510(k) NO: K113815(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 27-MAR-12 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSULATION TESTER SPECTRUM SURGICAL SUPPLY CORP. 510(k) NO: K120416(TRADITIONAL) ATTN: DENNIS A KOVIT PHONE NO : 330 686 4550 4575 HUDSON DR. SE DECISION MADE: 27-MAR-12 STOW OH 44224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABACUS 5 DIATRON US INC 510(k) NO: K112755(TRADITIONAL) ATTN: MICHAEL SWITZER PHONE NO : 954 790 9550 14026 W. 107TH STREET SE DECISION MADE: 27-MAR-12 LENEXA KS 66215 2005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PERSONA KNEE SYSTEM ZIMMER INC. 510(k) NO: K113369(TRADITIONAL) ATTN: KELLI ANDERSON PHONE NO : 574 371 8087 P.O. BOX 708 SE DECISION MADE: 27-MAR-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICASE GUIDE MATERIALISE N.V. 510(k) NO: K111558(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 321 639 6280 TECHNOLOGIELAAN 15 SE DECISION MADE: 27-MAR-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDEPENDENCE SPACER GLOBE MEDICAL, INC. 510(k) NO: K120101(SPECIAL) ATTN: MERIAM YOUSSEF PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 27-MAR-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK BIO-RAD LABORATORIES, INC. 510(k) NO: K120504(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949 598 1285 9500 JERONIMO RD. SE DECISION MADE: 27-MAR-12 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIVO MR355 GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K120778(SPECIAL) ATTN: RUOQIAN LIU PHONE NO : 861 058 068943 NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 27-MAR-12 BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE PERSONAL LUBRICANT (SILICONE) ONE 510(k) NO: K110690(ABBREVIATED) ATTN: SHARON PIETILA PHONE NO : 617 946 2800 12 CHANNEL STREET SE DECISION MADE: 28-MAR-12 BOSTON MA 02210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) BAYER HEALTHCARE, LLC 510(k) NO: K110587(TRADITIONAL) ATTN: CHUCK RYAN PHONE NO : 914 333 6736 555 WHITE PLAINS ROAD SE DECISION MADE: 28-MAR-12 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER BAYER HEALTHCARE 510(k) NO: K110894(TRADITIONAL) ATTN: ROGER SONNENBURG PHONE NO : 574 256 3441 430 SOUTH BEIGER STREET SE DECISION MADE: 28-MAR-12 MISHAWAKA IN 46544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA XP ND: YAG LASER SYSTEM FOTONA D.D. 510(k) NO: K113702(TRADITIONAL) ATTN: STOJAN TROST PHONE NO : 386 150 09100 STEGNE 7, SE DECISION MADE: 28-MAR-12 LJUBLJANA SI 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRAG LATERAL FLOW ASSAY (LFA) IMMUNO-MYCOLOGICS, INC. 510(k) NO: K112422(TRADITIONAL) ATTN: SEAN K BAUMAN PHONE NO : 405 360 4669 2700 TECHNOLOGY PLACE SE DECISION MADE: 28-MAR-12 NORMAN OK 73071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLIPSE PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K113695(TRADITIONAL) ATTN: JOHN MCLNTYRE PHONE NO : 949 837 3600 13900 Alton Pkwy Ste 123 SE DECISION MADE: 28-MAR-12 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTPILOT VIEW MODEL MK04500 DRAEGER MEDICAL GMBH 510(k) NO: K103035(TRADITIONAL) ATTN: JOYCE KILROY PHONE NO : 215 660 2626 3135 QUARRY ROAD SE DECISION MADE: 28-MAR-12 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR JIANGSU HEALTHY WAY MEDICAL EQUIPM510(k) NO: K112948(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 INDUSTRIAL RESEARCH SOCIETY NO.58 SE DECISION MADE: 28-MAR-12 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR JIANGSU HEALTHY MEDICAL EQUIPMENT 510(k) NO: K112950(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 INDUSTRIAL RESEARCH SOCIETY NO.58.SE DECISION MADE: 28-MAR-12 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-ANALYTE CHEMISTRY STANDARDS VERICHEM LABORATORIES, INC. 510(k) NO: K112834(ABBREVIATED) ATTN: ANTHONY JAMES DIMONTE PHONE NO : 401 461 0180 90 NARRAGANSETT AVE. SE DECISION MADE: 28-MAR-12 PROVIDENCE RI 02907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUASHIELD CO2 SYSTEM UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K120123(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 28-MAR-12 MENTOR OH 44060 510(k) STATEMENT DEVICE: GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL APEX BIOTECHNOLOGY CORP. 510(k) NO: K113547(TRADITIONAL) ATTN: HSUE-MEI LEE PHONE NO : 886 356 41952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-MAR-12 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REXIOUS HOOK FIXATION SYSTEMS DIO MEDICAL CO., LTD. 510(k) NO: K113324(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 28-MAR-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESIGLASS PASTE SHOFU DENTAL CORPORATION 510(k) NO: K112307(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 28-MAR-12 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: BD RECYKLEEN SHARPS COLLECTORS BECTON, DICKINSON AND COMPANY 510(k) NO: K112774(TRADITIONAL) ATTN: EILEEN HILLER PHONE NO : 201 847 4570 1 BECTON DRIVE MC 372 SE DECISION MADE: 28-MAR-12 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K113243(TRADITIONAL) ATTN: CYNTHIA HUNG PHONE NO : 886 366 86868 NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 28-MAR-12 HSINCHU CITY TW 30077 510(k) STATEMENT DEVICE: AZUR DETACHABLE 18 MICRO VENTION, INC. 510(k) NO: K120630(SPECIAL) ATTN: CYNTHIA VALENZUELA PHONE NO : 714 247 8000 1311 VALENCIA AVENUE SE DECISION MADE: 28-MAR-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZAVATION IBF SYSTEM ZAVATION LLC 510(k) NO: K120576(SPECIAL) ATTN: JOHN WALKER PHONE NO : 601 919 1119 501 AVALON WAY SE DECISION MADE: 28-MAR-12 BRANDON MS 39047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 BIONIME CORPORATION 510(k) NO: K110737(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 29-MAR-12 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCOMPASS ANORECTAL MANOMETRY SYSTEM MEDSPIRA, LLC 510(k) NO: K120088(TRADITIONAL) ATTN: JIM QUACKENBUSH PHONE NO : 612 789 0013 2718 SUMMER STREET NE SE DECISION MADE: 29-MAR-12 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACDS ISOPURE CORP. 510(k) NO: K120005(SPECIAL) ATTN: KEVIN GILLESPIE PHONE NO : 502 722 1000 141 CITIZENS BLVD. SE DECISION MADE: 29-MAR-12 SIMPSONVILLE KY 40067 6548 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFANT ARRAY ADVANCED IMAGING RESEARCH DBA SREE510(k) NO: K113365(TRADITIONAL) ATTN: RAVI SPRINIVASAN PHONE NO : 216 426 1461 PO BOX 603220 SE DECISION MADE: 29-MAR-12 CLEVELAND OH 44103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN ACTA MEDICAL L.L.C. 510(k) NO: K112863(TRADITIONAL) ATTN: AARON COMPTON PHONE NO : 214 533 1416 929 ARBOR DOWNS DRIVE SE DECISION MADE: 29-MAR-12 PLANO TX 75023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM SHEN WEI (USA), INC. 510(k) NO: K113233(TRADITIONAL) ATTN: ALBERT LI PHONE NO : 510 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 29-MAR-12 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM STRYKER CORP. 510(k) NO: K113327(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 29-MAR-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED EAR THEROMETER FUDAKANG INDUSTRIAL CO LTD 510(k) NO: K111703(TRADITIONAL) ATTN: DANIEL NAM PHONE NO : 213 626 1544 205 S. BROADWAY, SUITE 718 SE DECISION MADE: 29-MAR-12 LOS ANGELES CA 90012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKING COMPRESSION PLATE SYSTEM SHANGHAI MICROPORT ORTHOPEDICS CO.510(k) NO: K112798(TRADITIONAL) ATTN: JASON MA PHONE NO : 862 138 954600 588 TIANXIONG RD. BUILDING 23 SE DECISION MADE: 29-MAR-12 SHANGHAI CH 201318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS IMPERIAL SURGICAL LTD. 510(k) NO: K112702(TRADITIONAL) ATTN: KATHRYN RONALDS PHONE NO : 4 INNOVATION DRIVE SE DECISION MADE: 29-MAR-12 DUNDAS CA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K112538(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 29-MAR-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER SPINE SYSTEM CORELINK LLC 510(k) NO: K113058(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET 12TH FLOOR SE DECISION MADE: 29-MAR-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMPS MEDTRONIC MINIMED 510(k) NO: K120206(SPECIAL) ATTN: TAMAR JAGHASBANIAN PHONE NO : 818 576 3143 18000 DEVONSHIRE ST. SE DECISION MADE: 29-MAR-12 NORTHRIDGE CA 91325 1219 510(k) STATEMENT DEVICE: TOSHIBA 1.5T QD HEAD COIL QUALITY ELECTRODYNAMICS 510(k) NO: K120627(TRADITIONAL) ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228 700 BETA DRIVE SUITE 100 SE DECISION MADE: 29-MAR-12 MAYFIELD VILLAGE OH 44143 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM OSTIAL CORPORATION 510(k) NO: K120738(SPECIAL) ATTN: KAITLIN VON HOFFMANN PHONE NO : 650 903 9100 510 CLYDE AVENUE SE DECISION MADE: 29-MAR-12 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 SPACELABS MEDICAL, INC. 510(k) NO: K120616(SPECIAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 29-MAR-12 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPAP ST-A RESMED LTD. 510(k) NO: K113288(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 29-MAR-12 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. 510(k) NO: K120568(SPECIAL) ATTN: ARUL STERLIN PHONE NO : 510 864 4310 1360 SOUTH LOOP RD. SE DECISION MADE: 29-MAR-12 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGER II ANGIOGRAPHIC CATHETERS BOSTON SCIENTIFIC CORP. 510(k) NO: K120893(SPECIAL) ATTN: ANNE V ROSSI PHONE NO : 763 255 0681 ONE SCIMED PLACE SE DECISION MADE: 29-MAR-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCOLADE II HIP STEM HOWMEDICA OSTEONICS 510(k) NO: K120578(SPECIAL) ATTN: VALERIE GIAMBANCO PHONE NO : 325 CORPORATE DRIVE SE DECISION MADE: 29-MAR-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS BIO-RAD LABORATORIES 510(k) NO: K103834(TRADITIONAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 30-MAR-12 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS ANGIODYNAMICS, INC. 510(k) NO: K112452(SPECIAL) ATTN: TERI JUCKETT PHONE NO : 518 795 1142 14 PLAZA DRIVE SE DECISION MADE: 30-MAR-12 LATHAM NY 12110 510(k) STATEMENT DEVICE: URETRON MODEL URT MED-SONICS CORP 510(k) NO: K111058(ABBREVIATED) ATTN: WILLIAM A STOLL PHONE NO : 814 899 6500 5451 MERWIN LANE, SUITE 203 SE DECISION MADE: 30-MAR-12 ERIE PA 16510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRATORY HUMIDIFER FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K110019(TRADITIONAL) ATTN: ADELE BINDON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE P.O. BOX 1SE DECISION MADE: 30-MAR-12 AUCKLAND NZ 1741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTUNE SLEEP APNEA SYSTEM APNICURE, INC. 510(k) NO: K111549(TRADITIONAL) ATTN: CHRIS DANIEL PHONE NO : 650 361 9300 900 CHESAPEAKE DR SE DECISION MADE: 30-MAR-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC CIBA VISION CORPORATION 510(k) NO: K113168(TRADITIONAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678 415 3924 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 30-MAR-12 DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLE T NASAL MASK RESPIRONICS INC. 510(k) NO: K120145(SPECIAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 1001 Murry Ridge Ln SE DECISION MADE: 30-MAR-12 MURRYSVILLE PA 15668 510(k) STATEMENT DEVICE: ETCH-RITE SUPREME PULPDENT CORPORATION 510(k) NO: K120213(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 Oakland St SE DECISION MADE: 30-MAR-12 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE ECHOPAC GE HEALTHCARE 510(k) NO: K120221(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W. INNOVATION DRIVE RP-2138 SE DECISION MADE: 30-MAR-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME CYSTATIN C POC TEST KIT DIAZYME LABORATORIES 510(k) NO: K111664(TRADITIONAL) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 30-MAR-12 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA BETTINI S.P.A. 510(k) NO: K113431(TRADITIONAL) ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630 110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 30-MAR-12 ORMOND BEACH FL 32176 510(k) STATEMENT DEVICE: KITTYCAT CATHETER, KITTYCAT 2 CATHETER AVINGER, INC. 510(k) NO: K120273(TRADITIONAL) ATTN: ALBERT BONISKE PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE STE 100 SE DECISION MADE: 30-MAR-12 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC. 510(k) NO: K120378(TRADITIONAL) ATTN: MICHIO TAKIGAWA PHONE NO : 813 670 11706 OTE CENTER BLDG. 7F, 1-1-3, OTEMACSE DECISION MADE: 30-MAR-12 CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC. 510(k) NO: K120379(TRADITIONAL) ATTN: MICHIO TAKIGAWA PHONE NO : 813 670 11706 OTE CENTER BLDG. 7F, 1-1-3, OTEMACSE DECISION MADE: 30-MAR-12 CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT MICROPHAGE, INC. 510(k) NO: K120563(TRADITIONAL) ATTN: DREW SMITH PHONE NO : 303 652 5049 2400 Trade Centre Ave SE DECISION MADE: 30-MAR-12 Longmont CO 80503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARISURE NEUTRAL VALVE YUKON MEDICAL, LLC 510(k) NO: K120799(TRADITIONAL) ATTN: CARL DUPPER PHONE NO : 919 595 8257 4819-400 EMPEROR BLVD SE DECISION MADE: 30-MAR-12 DURHAM NC 27703 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRA BEAUTY JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K112351(TRADITIONAL) ATTN: POOJA JOHARI PHONE NO : 858 657 9226 ELECTRONIC HARDWARE TECHNOLOGY PARSE DECISION MADE: 30-MAR-12 BORANADA, JODHPUR, RAJASTHAN IN510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 272 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 22