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Medical Devices

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: 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: 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: 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: CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
WILLIAM COOK EUROPE APS           510(k) NO: K112119(TRADITIONAL)
ATTN: JENNIFER  BROWN             PHONE NO : 765 463 7537   
ONE GEDDES WAY                    SE DECISION MADE: 30-MAR-12
WEST LAFAYETTE IN 47906           510(k) SUMMARY AVAILABLE FROM FDA

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   273                                     
                                                 TOTAL WITH SUMMARIES        251                                     
                                                 TOTAL WITH STATEMENTS        22
                                      

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