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U.S. Department of Health and Human Services

Medical Devices

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November 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2011


DEVICE: UC-CARE NAVIGO SYTEM
UC-CARE LTD.                      510(k) NO: K100784(TRADITIONAL)
ATTN: JOHN  KAHAN                 PHONE NO : 202 637 5794   
555 THIRTEENTH STREET NW COLUMBIA SE DECISION MADE: 01-NOV-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOLTOUCH
NEW STAR LASERS, INC.             510(k) NO: K103338(TRADITIONAL)
ATTN: NATALIE R VOLLRATH          PHONE NO : 916 677 1900   
9085 FOOTHILLS BLVD.              SE DECISION MADE: 01-NOV-11
ROSEVILLE CA 95747                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LCI OPTION FOR INNOCOR
INNOVISION A/S                    510(k) NO: K102047(TRADITIONAL)
ATTN: H. CARL  JENKINS            PHONE NO : 847 234 7500   
10 E. SCRANTON AVE., SUITE 201    SE DECISION MADE: 01-NOV-11
LAKE BLUFF IL 60044               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUS BALLOON
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K111028(TRADITIONAL)
ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 01-NOV-11
MENTOR OH 44060                   510(k) STATEMENT

DEVICE: EYE-CEPT STERILE SALINE SOLUTION
OPTICS LABORATORY, INC            510(k) NO: K110221(TRADITIONAL)
ATTN: PATRICIA  CHIU              PHONE NO : 626 350 1926   
9480 TELSTAR AVE SUITE 3          SE DECISION MADE: 01-NOV-11
EL MONTE CA 91731 2988            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K112932(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 01-NOV-11
CHENGDU    CH 610041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODY ANALYSIS SCALE
SHENZHEN HEALTHCARE ELECTRONIC TEC510(k) NO: K112951(SPECIAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 01-NOV-11
ECHO OR 97826                     510(k) STATEMENT

DEVICE: BIOCERAMIC ORBITAL IMPLANT, ORBTEX
CERAMISYS LTD.                    510(k) NO: K110554(TRADITIONAL)
ATTN: HILLARD W WELCH             PHONE NO : 508 771 6777   
344 ANNABELLE POINT ROAD          SE DECISION MADE: 02-NOV-11
CENTERCILLE MA 02632 2402         510(k) STATEMENT

DEVICE: MEDICAL MAGGOTS, LESOC
MONARCH LABS, LLC.                510(k) NO: K102827(SPECIAL)
ATTN: RONALD  SHERMAN             PHONE NO : 949 679 3000   
17875 SKY PARK CIRCLE, SUITE K    SE DECISION MADE: 02-NOV-11
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNA-EXTOR II
BK MEDITECH CO., LTD.             510(k) NO: K110426(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
PO BOX 560                        SE DECISION MADE: 02-NOV-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
SPACELABS MEDICAL INC.            510(k) NO: K112962(SPECIAL)
ATTN: DAVVID J GERAGHTY           PHONE NO : 425 657 7200   
5150 220TH AVE SE                 SE DECISION MADE: 02-NOV-11
ISSAQUAH WA 98029                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
KIMBERLY-CLARK CORPORATION        510(k) NO: K113036(SPECIAL)
ATTN: LORI  BARR                  PHONE NO : 920 721 4570   
2001 MARATHON AVE                 SE DECISION MADE: 02-NOV-11
NEEAH WI 54956                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BINGO PRO
FORUM ENGINEERING TECHNOLOGIES (96510(k) NO: K111474(TRADITIONAL)
ATTN: YULIYA  YUTKEVICH           PHONE NO : 972 396 25517
1 PLATIN ST. NEW INDUSTRIAL ZONE  SE DECISION MADE: 02-NOV-11
RISHON LEZION    IS 75653         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOURSNARE VASCULAR RETRIEVAL SNARE
COOK, INC.                        510(k) NO: K112185(TRADITIONAL)
ATTN: MOLLY  BUSENBARK            PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 02-NOV-11
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFLEX BALLON GUIDE CATHETER
REVERSE MEDICAL CORPORATION       510(k) NO: K112262(TRADITIONAL)
ATTN: JEFFREY  VALKO              PHONE NO : 949 215 0660   
13700 ALTON PARKWAY SUITE 167     SE DECISION MADE: 02-NOV-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANO SUTURE ANCHOR
LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K112965(SPECIAL)
ATTN: ASHLEA  RICCI               PHONE NO : 727 399 5564   
11311  Concept Boulevard          SE DECISION MADE: 02-NOV-11
LARGO FL 33773                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
THE SEE CLEAR COMPANY, INC        510(k) NO: K111345(TRADITIONAL)
ATTN: KEVIN  RANDALL              PHONE NO : 303 828 0844   
16576 W. 53RD WAY                 SE DECISION MADE: 02-NOV-11
GOLDEN CO 80403                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
PHYGEN, LLC                       510(k) NO: K112931(SPECIAL)
ATTN: HARTMUT  LOCH               PHONE NO : 949 271 2417   
2301 Dupont Drive, Suite 510      SE DECISION MADE: 02-NOV-11
Irvine CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
VECTRACOR, INC                    510(k) NO: K102378(TRADITIONAL)
ATTN: BRAD S SCHRECK              PHONE NO : 973 768 0402   
169 UNION BLVD                    SE DECISION MADE: 02-NOV-11
TOTOWA NJ 07512                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC MAS OMNI-CORE
MICROGENICS CORPORATION           510(k) NO: K110738(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD.               SE DECISION MADE: 03-NOV-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110989(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 03-NOV-11
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
LIGHTMED CORP.                    510(k) NO: K103547(TRADITIONAL)
ATTN: JOCELYN  LIU                PHONE NO : 886 226 881726
NO.1-1, LANE1,PAO-AN ST. SEC.3    SE DECISION MADE: 03-NOV-11
SHULIN CITY    TW 238             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUTURA
DR. OLIVER WENKER, M.D., M.B.A.   510(k) NO: K102524(TRADITIONAL)
ATTN: COURTLAND  IMEL             PHONE NO : 972 241 8374   
2300 VALLEY VIEW LANE, SUITE 230  SE DECISION MADE: 03-NOV-11
FARMERS BRANCH TX 75234           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI TORQUE CONNECT GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K112381(TRADITIONAL)
ATTN: KENNY  WALSH                PHONE NO : 353 913 85037
LAKE REGION MED INTL R&D CTR PARKMSE DECISION MADE: 03-NOV-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOVASCULAR LASER VEIN SYSTEM KIT
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K112299(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 03-NOV-11
GRANDVILLE MA 01034               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
INRAD INC.                        510(k) NO: K112945(SPECIAL)
ATTN: RYAN  GOOSEN                PHONE NO : 616 301 7800   
4375 DONKER CT SE                 SE DECISION MADE: 03-NOV-11
GRAND RAPIDS MI 49504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
BRACCO DIAGNOSTIC, INC.           510(k) NO: K111648(SPECIAL)
ATTN: TRACEY  ALEXANDER           PHONE NO : 609 524 2865   
532 BROADHOLLOW ROAD SUITE 126    SE DECISION MADE: 03-NOV-11
MELVILLE NY 11747                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROBONE DENTAL GRAFTING MATERIAL
CERAMISYS LTD                     510(k) NO: K103820(TRADITIONAL)
ATTN: HILLARD W WELCH             PHONE NO : 508 771 6777   
344 ANNABELLE POINT ROAD          SE DECISION MADE: 03-NOV-11
CENTERVILLE MA 02632 2402         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS SHOULDER SYSTEM
TORNIER                           510(k) NO: K111902(TRADITIONAL)
ATTN: SEVERINE  BONNETON          PHONE NO : 003 347 6613500
161 RUE LAVOISIER                 SE DECISION MADE: 03-NOV-11
MONTBONNOT, SAINT-ISMIER    FR 383510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTO MITRA YELLOW LASER
OPTO ELECTRONICA SA               510(k) NO: K111643(TRADITIONAL)
ATTN: PAULO  ANEAS LICHTI         PHONE NO : 55 16 21067029
JOAQUIM A.R. DE SOUZA ST. 1071 - JSE DECISION MADE: 03-NOV-11
SAO CARLOS, SAO PAULO    BR 13.563510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOHORIZONS ABUTMENTS FOR ZIMMER
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K103691(TRADITIONAL)
ATTN: MICHAEL  DAVIS              PHONE NO : 205 967 7880   
2300 RIVERCHASE CENTER            SE DECISION MADE: 03-NOV-11
BIRMINGHAM AL 35244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX 13400
IMPEDIMED LIMITED                 510(k) NO: K100811(TRADITIONAL)
ATTN: ALDEN  KAY                  PHONE NO : 617 386 03700
5959 CORNERSTONE COURT WEST SUITE SE DECISION MADE: 04-NOV-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K103291(TRADITIONAL)
ATTN: MICHAEL  DAVIS              PHONE NO : 205 967 7880   
2300 RIVERCHASE CENTER            SE DECISION MADE: 04-NOV-11
BIRMINGHAM AL 35244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERDRY SILVER
MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K110715(TRADITIONAL)
ATTN: BRIAN J LINDSAY             PHONE NO : 864 503 1323   
920 MILLIKEN ROAD                 SE DECISION MADE: 04-NOV-11
SPARTANBURG SC 29303              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERFSCAPE V2.0
OLEA MEDICAL                      510(k) NO: K111161(TRADITIONAL)
ATTN: KRISTI  GUSMAN              PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 04-NOV-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FXA (TM)
ACES GMBH                         510(k) NO: K110765(TRADITIONAL)
ATTN: FRANK T TRAUTWEIN           PHONE NO : 497 117 874162
LUDWIGSTR. 26                     SE DECISION MADE: 04-NOV-11
FILDERSTADT, BW    GM 70794       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDISIZE RED AND MEDISIZE BLUE
QSERVE AMERICA, INC.              510(k) NO: K110246(SPECIAL)
ATTN: WILLIAM  GREENROSE          PHONE NO : 603 369 3550   
220 RIVER RD.                     SE DECISION MADE: 04-NOV-11
CLAREMONT NH 03743 5647           510(k) STATEMENT

DEVICE: ASCENSION NUGRIP CMC IMPLANT
ASCENSION ORTHOPEDIC              510(k) NO: K112278(TRADITIONAL)
ATTN: BRADLEY W STRASSER          PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 04-NOV-11
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M VISUM ALERT ALARM MANAGEMENT SYSTEM
MVISUM, INC.                      510(k) NO: K112282(TRADITIONAL)
ATTN: PRAVEEN  DALA               PHONE NO : 856 513 0732   
200 FEDERAL STREET SUITE 230      SE DECISION MADE: 04-NOV-11
CAMDEN NJ 08103                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K103021(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 04-NOV-11
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIMED CLAVICLE FIXATION SYSTEM
TRIMED, INC.                      510(k) NO: K112509(TRADITIONAL)
ATTN: DOUG  STEINBERGER           PHONE NO : 661 255 7406   
27533 AVENUE HOPKINS              SE DECISION MADE: 04-NOV-11
SANTA CLARITA CA 91355            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
WOOJEON COMPANY                   510(k) NO: K111392(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 04-NOV-11
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
PT. INTAN HEVEA INDUSTRY          510(k) NO: K111923(ABBREVIATED)
ATTN: DARWIN  TANDJO              PHONE NO : 626 168 50169
JL. PULAU IRIAN (KAWASAN IND. MEDASE DECISION MADE: 04-NOV-11
SUDARSO KM. 10,5, MEDAN    ID 2024510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLY-CHEM 90 ISE MODULE
POLYMEDCO, INC.                   510(k) NO: K112408(TRADITIONAL)
ATTN: HELEN  LANDICHO             PHONE NO : 206 402 6146   
510 FURNACE DOCK RD.              SE DECISION MADE: 04-NOV-11
CORTLANDT MANOR NY 10567          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
BECKMAN COULTER, INC.             510(k) NO: K112603(ABBREVIATED)
ATTN: CINDY  MCGUIRE              PHONE NO : 952 368 1142   
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 04-NOV-11
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFTKAR PT
SANO TRANSPORTGERAETE GMBH        510(k) NO: K111858(TRADITIONAL)
ATTN: JEANINE A CARROCCIO         PHONE NO : 630 891 2817   
428 BELLEAIRE LANE                SE DECISION MADE: 04-NOV-11
DOWNERS GROVE IL 60515            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
RESPIRONICS INC.                  510(k) NO: K111885(SPECIAL)
ATTN: JOSEPH E OLSAVSKY           PHONE NO : 724 387 7562   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 04-NOV-11
MONROEVILLE PA 15146              510(k) STATEMENT

DEVICE: MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...
TGM MEDICAL, INC.                 510(k) NO: K112285(TRADITIONAL)
ATTN: DENNIS H CRANE              PHONE NO : 952 374 6012   
5145 Golden Foothill Parkway SuiteSE DECISION MADE: 04-NOV-11
El Dorado Hills CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K112142(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   
P.O. BOX 6101                     SE DECISION MADE: 04-NOV-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO-JET CRYSTAL
LANG DENTAL MFG. CO., INC.        510(k) NO: K112397(TRADITIONAL)
ATTN: DAVID  LANG                 PHONE NO : 847 215 6622   
P.O BOX 969                       SE DECISION MADE: 04-NOV-11
WHEELING IL 60090 0969            510(k) STATEMENT

DEVICE: IT/IF CONTROL
SEBIA                             510(k) NO: K101863(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 770 446 3707   
1705 CORPORATE DRIVE SUITE 400    SE DECISION MADE: 07-NOV-11
NORCROSS GA 30093                 510(k) STATEMENT

DEVICE: NUFACE PLUS
CAROL COLE COMPANY                510(k) NO: K103472(ABBREVIATED)
ATTN: BOB  DUFFY                  PHONE NO : 858 487 1859   
16405 SUMMER SAGE RD              SE DECISION MADE: 07-NOV-11
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S6 DIAGNOSTIC ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K112602(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 07-NOV-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAMINAR FLOW PHACO TIPS
ABBOTT MEDICAL OPTICS INC         510(k) NO: K111882(ABBREVIATED)
ATTN: ROSANNE M YETEMIAN          PHONE NO : 714 247 8282   
1700 EAST SAINT ANDREW PL         SE DECISION MADE: 07-NOV-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES ZERO-P VARIABLE ANGLE (VA)
SYNTHES SPINE CO.LP               510(k) NO: K112068(TRADITIONAL)
ATTN: STACEY  BONNELL             PHONE NO : 610 719 5895   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 07-NOV-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
TOTOKU ELECTRIC CO., LTD          510(k) NO: K112145(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258 246611
300 OYA                           SE DECISION MADE: 07-NOV-11
UEDA, NAGANO    JA 386-0192       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FM20
MEDIANA CO., LTD.                 510(k) NO: K110612(TRADITIONAL)
ATTN: AMY  KIM                    PHONE NO : 823 374 25400
WONJU MEDICAL IND. PARK 1650-1 DONSE DECISION MADE: 08-NOV-11
WONJU-SI, GANGWON-DO    KS 220-801510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
HORIBA ABX SAS                    510(k) NO: K103788(TRADITIONAL)
ATTN: CAROLINE  FERRER            PHONE NO : 33 467 141516
PARC EUROMEDECINE RUE DU CADUCEE -SE DECISION MADE: 08-NOV-11
MONTPELLIER    FR 34184           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
ABBCONCISE OPTICAL GROUP, LLC     510(k) NO: K111267(TRADITIONAL)
ATTN: MARTIN  DALSINGH            PHONE NO : 970 243 5490   
806 KIMBALL AVENUE                SE DECISION MADE: 08-NOV-11
GRAND JUNCTION CO 81501           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIR HEAT THERAPHY SYSYEMS
SHENZHEN ANPAN TECHNOLOGY CO., LTD510(k) NO: K111273(TRADITIONAL)
ATTN: WANG  TAO                   PHONE NO : 867 558 9640313862
#44, 2ND ROAD, XIAKENG, TONGLE COMSE DECISION MADE: 08-NOV-11
SHENZHEN    CH 518116             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTERAL FEEDING BAG AND SETS
SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K102741(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 08-NOV-11
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROW FUSION
NLT SPINE LTD                     510(k) NO: K112359(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 5600   
555 THIRTEENTH STREET NW          SE DECISION MADE: 08-NOV-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS           510(k) NO: K111615(TRADITIONAL)
ATTN: CYNTHIA C KNAPP             PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE                SE DECISION MADE: 08-NOV-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: CALIX PC SPINAL IMPLANT SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K112036(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 08-NOV-11
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSEAL G2 TISSUS SEALERS
ETHICON ENDO-SUGERY, LLC          510(k) NO: K112033(TRADITIONAL)
ATTN: DONOVAN  MAY                PHONE NO : 513 337 7981   
4545 CREEK RD.                    SE DECISION MADE: 08-NOV-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBER DISK AND BLOCK
BIOLOREN SRL                      510(k) NO: K112186(TRADITIONAL)
ATTN: ANDREA  RATTI               PHONE NO : 39 029 6703261
VIA ALESSANDRO VOLTA 59           SE DECISION MADE: 08-NOV-11
SARONNO    IT --                  510(k) STATEMENT

DEVICE: HI-TORQUE POWERTURN
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K112957(TRADITIONAL)
ATTN: KAY  SETZER                 PHONE NO : 951 914 3242   
26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 08-NOV-11
TEMECULA CA 92589 9018            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
HEIDELBERG ENGINEERING GMBH       510(k) NO: K113129(TRADITIONAL)
ATTN: GERGARD  ZINSER             PHONE NO : 496 221 64630
TIERGARTENSTRASSE 15              SE DECISION MADE: 08-NOV-11
HEIDELBERG    GM 69121            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACKERMANN EUROPCLIP
ACKERMANN INSTRUMENTE GMBH        510(k) NO: K111930(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 08-NOV-11
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRANDIO CORE DUAL CURE
VOCO GMBH                         510(k) NO: K112447(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 494 721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 08-NOV-11
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K111692(SPECIAL)
ATTN: HARALD  JUNG                PHONE NO : 497 461 969236
UNTERER WINKEL 3                  SE DECISION MADE: 08-NOV-11
WURMLINGEN    GM 78573            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
NANOVIS, LLC                      510(k) NO: K110442(TRADITIONAL)
ATTN: KEVIN A THOMAS, PHD         PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 09-NOV-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELAMON PEEK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K110562(TRADITIONAL)
ATTN: REGINA  HOLMES              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 09-NOV-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIRO PD
PMD HEALTHCARE                    510(k) NO: K103575(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410 451 0639   
1468 HARWELL AVE.                 SE DECISION MADE: 09-NOV-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERPRESS UNIT
HANURI DISTRIBUTION, INC          510(k) NO: K110276(TRADITIONAL)
ATTN: JUNG  HYUN MOON             PHONE NO : 818 998 1023   
9601 OWENSMOUTH AVENUE # 8        SE DECISION MADE: 09-NOV-11
CHATSWORTH CA 91311               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMELOCK CEMENTED SHOULDER PROSTHESIS
FX SOLUTIONS                      510(k) NO: K111097(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220
1663 RUE DE MAJORNAS              SE DECISION MADE: 09-NOV-11
VIRIAT    FR 01440                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T:SLIM (TM) INSULIN DELIVERY SYSTEM
TANDEM DIABETES CARE, INC.        510(k) NO: K111210(TRADITIONAL)
ATTN: DON  CANAL                  PHONE NO : 858 366 6963   
11045 ROSELLE STREET SUITE 200    SE DECISION MADE: 09-NOV-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
STINGRAY SURGICAL PRODUCTS, INC   510(k) NO: K102752(TRADITIONAL)
ATTN: MARK  MCBRINN               PHONE NO : 561 210 7582   
801 APPLE TREE LANE               SE DECISION MADE: 09-NOV-11
BOCA RATON FL 33486               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VELOCITY SYSTEM V.3.0
ST. JUDE MEDICAL                  510(k) NO: K112688(SPECIAL)
ATTN: DONNA R LUNAK               PHONE NO : 651 756 2944   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 09-NOV-11
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXERA ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K113110(SPECIAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 261 8073   
740 Bay Rd                        SE DECISION MADE: 09-NOV-11
Redwood City CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
SWEETSPOT DIABETES CARE, INC.     510(k) NO: K111509(TRADITIONAL)
ATTN: CHRIS  LOGAN                PHONE NO : 503 893 2448   
2538 NE 48TH AVE                  SE DECISION MADE: 09-NOV-11
PORTLAND OR 97213 1924            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
INTRICON DATRIX CORPORATION       510(k) NO: K112601(TRADITIONAL)
ATTN: TANYA  O'BRIEN              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 09-NOV-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPK REAGENT
VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K112416(TRADITIONAL)
ATTN: MELITA  LAMBIRIS            PHONE NO : 610 387 936300
189-199 BROWNS ROAD               SE DECISION MADE: 09-NOV-11
NOBLE PARK, VICTORIA    AS 3174   510(k) STATEMENT

DEVICE: ASIMANAGER - AT
ARLINGTON SCIENTIFIC, INC.        510(k) NO: K111356(TRADITIONAL)
ATTN: DAVID  BINKS                PHONE NO : 801 489 8911   
1840 NORTH TECHNOLOGY DR.         SE DECISION MADE: 09-NOV-11
SPRINGVILLE UT 84663              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASA 'MPHI FAMILY DIODE LASER
CYNOSURE, INC.                    510(k) NO: K111901(SPECIAL)
ATTN: ANTHONY  BURNS              PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 09-NOV-11
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CATHETER CONNECTIONS' DUALCAP DUO
CATHETER CONNECTIONS, INC.        510(k) NO: K112985(SPECIAL)
ATTN: DONALD D SOLOMON            PHONE NO : 801 209 1269   
615 Arapeen Dr Ste 302A           SE DECISION MADE: 09-NOV-11
Salt Lake City UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
NORTHSTAR HEALTHCARE HOLDINGS LIMI510(k) NO: K112988(TRADITIONAL)
ATTN: ANTONIO L GIACCIO           PHONE NO : 815 385 0100   
1202 SOUTH ROUTE 31               SE DECISION MADE: 09-NOV-11
MCHENRY IL 60050                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FD TENS 2050 OR SLIDE TENS MODEL FD2050
FUJI DYNAMICS LTD                 510(k) NO: K111645(TRADITIONAL)
ATTN: CHING KONG  (FELIX) LEE     PHONE NO : 852 27 864218
UNIT 1-3, 23/F LAWS COMMERICAL PLASE DECISION MADE: 09-NOV-11
HONG KONG    CH CH                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUBICON SUPPORT CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K112303(TRADITIONAL)
ATTN: GLENN  JACQUES              PHONE NO : 763 494 1152   
ONE SCIMED PLACE                  SE DECISION MADE: 09-NOV-11
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR
MEDIANA CO., LTD.                 510(k) NO: K112190(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 09-NOV-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERCON HT
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K112152(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 845 7511   
SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 09-NOV-11
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFUNCTION KEITO
AGUIFLAI IBERICA S.L.             510(k) NO: K103058(TRADITIONAL)
ATTN: XAVIER  CASALS              PHONE NO : 349 375 40370
LA PUJADA 19                      SE DECISION MADE: 10-NOV-11
VILASSAR DE MAR (BARCELONA)    SP 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BMR FACE
BIO-MEDICAL RESEARCH, LTD.        510(k) NO: K103031(TRADITIONAL)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 917 74316
BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 10-NOV-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
NORAV MEDICAL LTD.                510(k) NO: K110463(SPECIAL)
ATTN: BENRY  ARAZY                PHONE NO : 972 499 47880
INDUSTRIAL PARK 13 M.P. MISGAV    SE DECISION MADE: 10-NOV-11
MITZPE AVIV    IS 20187           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXGEN EXPANDABLE CATHETER
NEXGEN MEDICAL SYSTEMS, INC.      510(k) NO: K102925(TRADITIONAL)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728 0126   
1050 W. NASA BLVD. SUITE 136      SE DECISION MADE: 10-NOV-11
MELBOURNE FL 32901                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-FORCE
SEVEN SEAS DISTRIBTION AND MANUFAC510(k) NO: K111557(TRADITIONAL)
ATTN: MARK  IOELE                 PHONE NO : 213 613 2356   
2620 S MARYLAND PKWY STE 14 UNIT 8SE DECISION MADE: 10-NOV-11
LAS VEGAS NV 89109                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
NORAN MEDICAL CORP.               510(k) NO: K111487(SPECIAL)
ATTN: BENNY  ARAZY                PHONE NO : 972 49 947880
INDUSTRIAL PARK 13, M.P. MISGAV   SE DECISION MADE: 10-NOV-11
MITZPE AVIV    IS 20187           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K113019(SPECIAL)
ATTN: MATT  PAUL                  PHONE NO : 901 367 4350   
5677 AIRLINE RD.                  SE DECISION MADE: 10-NOV-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMEDITECH IMMUTEST MILTI-DRUG SCREEN
AMEDITECH, INC.                   510(k) NO: K113046(SPECIAL)
ATTN: GREG  CERRA                 PHONE NO : 858 805 8713   
10340 CAMINO SANTA FE SUITE F     SE DECISION MADE: 10-NOV-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
COMPRESSION THERAPY CONCEPTS, INC.510(k) NO: K112838(TRADITIONAL)
ATTN: LEONARD  NASS               PHONE NO : 732 544 0800   
35 JAMES WAY                      SE DECISION MADE: 10-NOV-11
EATONTOWN NJ 07724                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNOTLESS SUTURE FIXATION SYSTEM
CORE ESSENCE ORTHOPAEDICS         510(k) NO: K111716(TRADITIONAL)
ATTN: JEFF  MILLER                PHONE NO : 215 310 9534   
575A VIRIGINIA DR                 SE DECISION MADE: 10-NOV-11
FT. WASHINGTON PA 19034           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARTIS CONSOLE
PULMONX, INC.                     510(k) NO: K111764(SPECIAL)
ATTN: HANS  SCHULZ                PHONE NO : 650 364 0400   
700 CHESAPEAKE DRIVE              SE DECISION MADE: 10-NOV-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRACT SYRINGE KEY SYSTEM
XTRACT SOLUTIONS                  510(k) NO: K112475(TRADITIONAL)
ATTN: KEITH  LOWREY               PHONE NO : 503 206 4311   
9495 SW LOCUST SUITE E            SE DECISION MADE: 10-NOV-11
PORTLAND OR 97223                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IGLUCOSE SYSTEM
POSITIVEID CORPORATION            510(k) NO: K111932(TRADITIONAL)
ATTN: EDWARD  VALDEZ              PHONE NO : 561 805 8000   
1690 S. CONGRESS AVENUE Suite 200 SE DECISION MADE: 10-NOV-11
Delray Beach FL 33445             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM
ACTIVIEWS LTD                     510(k) NO: K113063(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 10-NOV-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPI VARIO ANGLED ABUTMENT
THOMMEN MEDICAL, AG               510(k) NO: K111984(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 10-NOV-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESSEL GUARDIAN
LEXION MEDICAL, LLC.              510(k) NO: K112357(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 855 1447   
545 ATWATER CIRCLE                SE DECISION MADE: 10-NOV-11
ST PAUL MN 55103                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR
SAMSUNG MOBILE DISPLAY CO., LTD   510(k) NO: K112558(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LANE              SE DECISION MADE: 10-NOV-11
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
VILEX, INC.                       510(k) NO: K102413(TRADITIONAL)
ATTN: ABE  LAVI                   PHONE NO : 941 373 3987   
111 MOFFITT STREET                SE DECISION MADE: 14-NOV-11
MCMINNVILLE TN 37110              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
ACUMED LLC                        510(k) NO: K112111(TRADITIONAL)
ATTN: LINO  TSAI                  PHONE NO : 503 627 9957   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 14-NOV-11
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
SMITH & NEPHEW, INC.              510(k) NO: K112406(TRADITIONAL)
ATTN: DAVID  HENLY                PHONE NO : 901 399 6487   
7135 GOODLET FARMS PARKWAY        SE DECISION MADE: 14-NOV-11
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIAN HIGH ENERGY LINEAR ACCELERATOR
VARIAN MEDICAL SYSTEMS            510(k) NO: K112839(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY M/S E-110         SE DECISION MADE: 14-NOV-11
PALO ALTO CA 94304 1129           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
KETTENBACH GMBH & CO KG           510(k) NO: K113279(SPECIAL)
ATTN: SIMONE  MATUSCHKA           PHONE NO : 492 774 70539
IM HEERFELD 7                     SE DECISION MADE: 14-NOV-11
ESCHENBURG    GM 35713            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K111843(TRADITIONAL)
ATTN: JANICE  HASELTON            PHONE NO : 978 749 1494   
150 MINUTEMAN RD.                 SE DECISION MADE: 14-NOV-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE FRACTIONAL LASER
PALOMAR MEDICAL PRODUCTS, INC.    510(k) NO: K111840(TRADITIONAL)
ATTN: SHARON  TIMBERLAKE          PHONE NO : 781 993 2414   
82 CAMBRIDGE ST.                  SE DECISION MADE: 14-NOV-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARGES IMAGING CONTRAST SPRAY
ARGES IMAGING, INC                510(k) NO: K113263(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
129 NORTH HILL AVENUE             SE DECISION MADE: 14-NOV-11
PASADENA CA 91106                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: REPROCESSED HAND ACTIVATE SEALER/DIVIDER
ASCENT HEALTHCARE SOLUTIONS       510(k) NO: K111600(TRADITIONAL)
ATTN: RAMONA  KULIK               PHONE NO : 480 763 2952   
10232 SOUTH 51ST ST.              SE DECISION MADE: 15-NOV-11
PHOENIX AZ 85044                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
MEDICA CORP.                      510(k) NO: K111005(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 175 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 15-NOV-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: SONOSITE EDGE ULTRASOUND SYSTEM
SONOSITE,INC.                     510(k) NO: K113156(TRADITIONAL)
ATTN: SCOTT  PAULSON              PHONE NO : 425 951 6926   
21919 30TH DRIVE SE.              SE DECISION MADE: 15-NOV-11
BOTHELL WA 98021 3904             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RSP GLENOID BASEPLATE POROUS COATED
ENCORE MEDICAL, L.P.              510(k) NO: K112069(TRADITIONAL)
ATTN: WILLIAM  GARZON             PHONE NO : 512 834 6391   
9800 METRIC BLVD.                 SE DECISION MADE: 15-NOV-11
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERISPINEPS PEDICLE SCREW
SAFE ORTHOPAEDICS                 510(k) NO: K112453(ABBREVIATED)
ATTN: PIERRE  DUMOUCHEL           PHONE NO : 330 321 056423
PARC DES BELLEVUES- ALLEE R LUXEMBSE DECISION MADE: 15-NOV-11
ERAGNY SUR OISE    FR 95610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K112444(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 15-NOV-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHTRACKER
WISTRON CORPORATION               510(k) NO: K110770(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
6TH FLOOR NO 127 WUGONG 2ND RD WUGSE DECISION MADE: 16-NOV-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
VENTANA MEDICAL SYTEMS, INC       510(k) NO: K103818(TRADITIONAL)
ATTN: GEORGE  DE LA ROSA          PHONE NO : 520 877 7061   
1910 E. INNOVATIONS PARK DRIVE    SE DECISION MADE: 16-NOV-11
TUCSON AZ 85755                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APOLLO
POLLOGEN LTD                      510(k) NO: K111026(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 16-NOV-11
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
SYNTHES INC                       510(k) NO: K111323(TRADITIONAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   
1301 GOSHEN PARKWAY               SE DECISION MADE: 16-NOV-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIZION
TREK DIAGNOSTIC SYSTEMS           510(k) NO: K112276(TRADITIONAL)
ATTN: CYNTHIA C KNAPP             PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE                SE DECISION MADE: 16-NOV-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
STRAUMANN USA                     510(k) NO: K112280(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 16-NOV-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113195(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 16-NOV-11
CHU XIAOAN    CH 100083           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNORERX 9.0
CONSUMER HEALTH PRODUCTS, INC     510(k) NO: K112205(ABBREVIATED)
ATTN: GARY  MOCNIK                PHONE NO : 949 433 0413   
49 COASTAL OAK                    SE DECISION MADE: 16-NOV-11
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
RENU MEDICAL, INC.                510(k) NO: K111773(TRADITIONAL)
ATTN: L BRUCE  PIERSON            PHONE NO : 425 353 1110   
9800 EVERGREEN WAY                SE DECISION MADE: 16-NOV-11
EVERETT WA 98204                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOYALA SILKGEL FULL FACE MASK
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K112167(SPECIAL)
ATTN: RALF  EGENOLF               PHONE NO : 49 40 54702370
KRONSAALSWEG 40                   SE DECISION MADE: 16-NOV-11
HAMBURG    GM 22525               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE PNEUMOPERITONEUM NEEDLE
MEDLINE, INDUSTRIES, INC.         510(k) NO: K111955(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 16-NOV-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: THE BELMONT BUDDY LITE FLUID WARMER
BELMONT INSTRUMENT CORP.          510(k) NO: K112639(SPECIAL)
ATTN: URAIWAN P LABADINI          PHONE NO : 978 663 0212   
780 BOSTON RD.                    SE DECISION MADE: 16-NOV-11
BILLERICA MA 01821                510(k) STATEMENT

DEVICE: HYPERELASTIC WIRE
ORMCO CORP.                       510(k) NO: K112640(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 16-NOV-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TASMAN
RESMED LTD.                       510(k) NO: K112393(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 16-NOV-11
KEARNEY MESA CA 92123             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL LASER THERAPY SYSTEM
CHINA DAHENG GROUP, INC.          510(k) NO: K113212(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 16-NOV-11
SHANGHAI, CHINA    CH 100085      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACCELEDENT
ORTHOACCEL TECHNOLOGIES, INC      510(k) NO: K110661(TRADITIONAL)
ATTN: MICHAEL E KAUFMAN           PHONE NO : 832 631 1657   
8275 EL RIO, SUITE 100            SE DECISION MADE: 17-NOV-11
HOUSTON TX 77054                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE MX40 PATIENT MONITOR
PHILIPS MEDICAL SYSTEMS           510(k) NO: K113125(SPECIAL)
ATTN: THERESA  POOLE              PHONE NO : 978 659 7621   
3000 MINUTEMAN RD.                SE DECISION MADE: 17-NOV-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113191(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 17-NOV-11
CHU XIAOAN    CH 100083           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES LCP PEDINTRIC PLATE SYSTEMS
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K112085(TRADITIONAL)
ATTN: ANGELA F LASSUNDER          PHONE NO : 601 719 6854   
1301 GOSHEN PKWY.                 SE DECISION MADE: 17-NOV-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARWAY RX NB CATHETER
ATRIUM MEDICAL CORP.              510(k) NO: K113112(SPECIAL)
ATTN: MEGAN  MCCAGH               PHONE NO : 603 880 1433   
5 WENTWORTH DR.                   SE DECISION MADE: 17-NOV-11
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: HY-BOND RESIGLASS
SHOFU DENTAL CORP.                510(k) NO: K111855(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DR.                    SE DECISION MADE: 17-NOV-11
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: MEMOMETAL INTRA-MEDULLARY BONE FASTENER
MEMOMETAL TECHNOLOGIES            510(k) NO: K112197(SPECIAL)
ATTN: GILLES  AUDIC               PHONE NO : 33 299 055969
CAMPUS DE KER LANN RUE BLAISE PASCSE DECISION MADE: 17-NOV-11
BRUZ    FR F35170                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL DC CORE PLUS
KURARAY AMERICA, INC.             510(k) NO: K111982(TRADITIONAL)
ATTN: KIYOYUKI  ARIKAWA           PHONE NO : 212 986 2230   
600 LEXINGTON AVE. 26TH FLOOR     SE DECISION MADE: 17-NOV-11
NEW YORK NY 10022                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DREAMBOND
BISCO, INC.                       510(k) NO: K112118(TRADITIONAL)
ATTN: MICHELLE  SCHILTZ-TAING     PHONE NO : 847 534 6146   
1100 WEST IRVING PARK RD.         SE DECISION MADE: 17-NOV-11
SCHAUMBURG IL 60193               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBCARDIO SYSTEM
MOBHEALTH INCORPORATION           510(k) NO: K113234(TRADITIONAL)
ATTN: PATRICIA  LIN               PHONE NO : 626 442 9886   
5227 VILLAGE CIRCLE DR.           SE DECISION MADE: 17-NOV-11
TEMPLE CITY CA 91780              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
ST. JUDE MEDICAL NEUROMODULATION  510(k) NO: K112214(TRADITIONAL)
ATTN: PENNY  HOUSTON              PHONE NO : 972 526 4840   
6901 PRESTON RD.                  SE DECISION MADE: 17-NOV-11
PLANO TX 75024                    510(k) STATEMENT

DEVICE: KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
MEDICATECH USA                    510(k) NO: K112132(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO COURT                SE DECISION MADE: 18-NOV-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
MEDTRONIC NEUROSURGERY            510(k) NO: K110560(TRADITIONAL)
ATTN: JEFFREY  HENDERSON          PHONE NO : 805 571 8400   
125 CREMONA DR.                   SE DECISION MADE: 18-NOV-11
GOLETA CA 93117                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGH FLOW INSUFFLATION UNIT UHI-4
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K110294(TRADITIONAL)
ATTN: STACY  ABBATIELLO KLUESNER  PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY            SE DECISION MADE: 18-NOV-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBU ASCOPE 2
AMBU A/S                          510(k) NO: K110962(TRADITIONAL)
ATTN: SANJAY  PARIKH              PHONE NO : 410 768 6464   
6740 BAYMEADOW DR.                SE DECISION MADE: 18-NOV-11
GLEN BURNIE MD 21060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
WIDE CORPORATION                  510(k) NO: K110596(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 18-NOV-11
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOTITE 2 DENTAL IMPLANTS
BIOMET 3I, INC.                   510(k) NO: K111216(SPECIAL)
ATTN: MARTHA I GARAY              PHONE NO : 561 776 6923   
4555 RIVERSIDE DR.                SE DECISION MADE: 18-NOV-11
PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIEZO BONE SURGERY
GUILIN WOODPECKER MEDICAL INSTRUME510(k) NO: K111290(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
7325 JOYCE WAY                    SE DECISION MADE: 18-NOV-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
SEPPIM S.A.S.                     510(k) NO: K103376(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 18-NOV-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
FOSHAN NANHAI BAI HE MEDICAL TECHN510(k) NO: K102833(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 18-NOV-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONCENTRA PROSTATE 4.0
NUCLETRON                         510(k) NO: K112420(TRADITIONAL)
ATTN: MICHAEL  PAUL               PHONE NO : 443 545 2182   
7021 COLUMBIA GATEWAY DRIVE SUITE SE DECISION MADE: 18-NOV-11
COLUMBIA MD 21046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
BM KOREA CO., LTD.                510(k) NO: K111593(TRADITIONAL)
ATTN: RONALD D ARKIN              PHONE NO : 770 565 6166   
1733 CANTON LANE                  SE DECISION MADE: 18-NOV-11
MARIETTA GA 30062 2670            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OBC BONE ANCHORED HEARING SYSTEM
OTICON MEDICAL AB                 510(k) NO: K112053(TRADITIONAL)
ATTN: KAROLIN  ISBERG JERNBY      PHONE NO : 460 317 486153
EKONOMIVAGEN 2                    SE DECISION MADE: 18-NOV-11
ASKIM    SW SE-436 33             510(k) STATEMENT

DEVICE: CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
CALYPSO MEDICAL TECHNOLOGIES INC  510(k) NO: K112768(TRADITIONAL)
ATTN: MARCIA  PAGE                PHONE NO : 206 774 4234   
2101 FOURTH AVE SUITE 500         SE DECISION MADE: 18-NOV-11
SEATTLE WA 98121                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES USS CONNECTORS
SYNTHES SPINE                     510(k) NO: K111358(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LN EAST              SE DECISION MADE: 18-NOV-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K112050(SPECIAL)
ATTN: MARINA  GUEVREKIAN          PHONE NO : 909 839 8714   
3333 DIAMOND CANYON RD            SE DECISION MADE: 18-NOV-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
ELITECHGROUP                      510(k) NO: K111960(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 18-NOV-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONCO TRAC MODEL 1, 2, 4
TRANSLATIONAL SCIENCES CORPORATION510(k) NO: K111642(TRADITIONAL)
ATTN: ALLEN  GREEN, MD, PHD, JD   PHONE NO : 617 447 5999   
ONE MIFFLIN PLACE SUITE 400       SE DECISION MADE: 18-NOV-11
CAMBRIDGE MA 02138                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAROTID COIL
SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K112002(TRADITIONAL)
ATTN: MEIJUAN  CHEN               PHONE NO : 862 152 961075833
BLDG 8, LANE 1199, JIDI ROAD      SE DECISION MADE: 18-NOV-11
SHANGHAI    CH 201107             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K111983(TRADITIONAL)
ATTN: KATHLEEN  RUTHERFORD        PHONE NO : 973 576 0139   
10 POMEROY RD.                    SE DECISION MADE: 18-NOV-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVO BARRIER TOPICAL EMULSION
TRIGEN LABORATORIES, INC.         510(k) NO: K110762(TRADITIONAL)
ATTN: GEORGE  MCCAULEY            PHONE NO : 803 831 7657   
248 LATITUDE LANE SUITE 104       SE DECISION MADE: 18-NOV-11
LAKE WYLIE SC 29710               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITREA CT MYOCARDIAL ANALYSIS
VITAL IMAGES, INC.                510(k) NO: K112531(TRADITIONAL)
ATTN: DANIEL  BIANK               PHONE NO : 952 487 9514   
5850 OPUS PARKWAY, SUITE 300      SE DECISION MADE: 18-NOV-11
MINNETONKA MN 55343 4414          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNDATION DENTAL RESIN
UNIX-JAPAN CO., LTD.              510(k) NO: K111709(TRADITIONAL)
ATTN: TOSHIKO  BOYD               PHONE NO : 310 435 6358   
10920 WILSHIRE BLVD SUITE 150     SE DECISION MADE: 18-NOV-11
LOS ANGELES CA 90024              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPAS CATHETER
THERMOPEUTIX INC.                 510(k) NO: K112219(TRADITIONAL)
ATTN: THOMAS  SCHROEDER           PHONE NO : 858 549 1760   
9925B BUSINESS PARK AVE.          SE DECISION MADE: 18-NOV-11
SAN DIEGO CA 92131                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSRADIAL ARTERY ACCESS DEVICES
TELEFLEX MEDICAL, INC.            510(k) NO: K112554(TRADITIONAL)
ATTN: CHRISTINE  FORD             PHONE NO : 610 378 0131   
2400 BERNVILLE ROAD               SE DECISION MADE: 18-NOV-11
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO VIA MI WORKFLOWS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113029(SPECIAL)
ATTN: ALAINE  MEDIO               PHONE NO : 865 218 2703   
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 18-NOV-11
HOFFMAN ESTATES IL 60192          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASS LP SPINAL SYSTEM
MEDICREA INTERNATIONAL            510(k) NO: K112493(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 21-NOV-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
SEJU ENGINEERING CO., LTD.        510(k) NO: K110614(TRADITIONAL)
ATTN: EILEEN  YANG                PHONE NO : 824 247 62977
CERTIFICATION DIVISION D-524 MIGUNSE DECISION MADE: 21-NOV-11
YUSEONG-GU, DAEJEON    KS 305-500 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K112551(SPECIAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 21-NOV-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIRODOC
MEDICAL INTERNATIONAL RESEARCH USA510(k) NO: K103530(TRADITIONAL)
ATTN: ED  KOHERE                  PHONE NO : 262 656 6797   
1900 PEWAUKEE ROAD SUITE O        SE DECISION MADE: 21-NOV-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
EXACTECH, INC.                    510(k) NO: K112097(TRADITIONAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 21-NOV-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K113174(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 21-NOV-11
Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLYDESDALES SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K112405(TRADITIONAL)
ATTN: JULIE  BASSETT              PHONE NO : 901 399 3248   
1800 PYRAMID PLACE                SE DECISION MADE: 21-NOV-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
ALCON MANUFACTURING, LTD.         510(k) NO: K112425(TRADITIONAL)
ATTN: MARTIN A KAUFMAN            PHONE NO : 949 753 6250   
15800 ALTON PKWY.                 SE DECISION MADE: 21-NOV-11
IRVINE CA 92618 3818              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHIBA SONO
PAJUNK GMBH                       510(k) NO: K113209(TRADITIONAL)
ATTN: CHRISTIAN  QUASS            PHONE NO : 049 770 49291586
KARL-HALL-STRASSE 1               SE DECISION MADE: 21-NOV-11
GEISINGEN    GM D-78187           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPONEER
COLTENE/WHALEDENT AG              510(k) NO: K112168(TRADITIONAL)
ATTN: MARK  VAN METER             PHONE NO : 330 916 8800   
235 ASCOT PARKWAY                 SE DECISION MADE: 21-NOV-11
CUYAHOGA FALLS OH 44223           510(k) STATEMENT

DEVICE: DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K112724(TRADITIONAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
325 PARAMOUNT DRIVE               SE DECISION MADE: 21-NOV-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUCLEAR OPERATIVE HYSTEROSCOPE
SMITH & NEPHEW, INC.              510(k) NO: K112134(TRADITIONAL)
ATTN: JANICE  HASELTON            PHONE NO : 978 749 1494   
150 MINUTEMAN RD.                 SE DECISION MADE: 22-NOV-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMTEC LASER SYSTEM FOR CAPSULOTOMY
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K110427(TRADITIONAL)
ATTN: BETTY M JOHNSON             PHONE NO : 714 273 8254   
PO BOX 17190                      SE DECISION MADE: 22-NOV-11
ANAHEIM CA 92817 7190             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIGRA TAB, QUICKSPLINT MIGRAINE
MIGRATHERAPY LLC                  510(k) NO: K111066(TRADITIONAL)
ATTN: BRADLEY  ELI                PHONE NO : 602 908 1680   
4403 MANCHESTER AVENUE, SUITE 103 SE DECISION MADE: 22-NOV-11
ENCINITAS CA 92024                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VTRUST FINGER TYPE PULSE OXIMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K110893(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 22-NOV-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANYRIDGE INTERNAL IMPLANT SYSTEM
MEGAGEN CO., LTD.                 510(k) NO: K110955(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE STREET UNIT B       SE DECISION MADE: 22-NOV-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFIRE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103424(TRADITIONAL)
ATTN: ALICIA  BUSTOS-JUERGENSEN   PHONE NO : 610 448 4056   
51 VALLEY STREAM PARKWAY, E-50    SE DECISION MADE: 22-NOV-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K112963(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 22-NOV-11
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARVISION
MIDMARK CORP.                     510(k) NO: K112380(TRADITIONAL)
ATTN: LISA  BARTAKOVICS           PHONE NO : 847 415 9800   
675 HEATHROW DRIVE                SE DECISION MADE: 22-NOV-11
LINCOLNSHIRE IL 60069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENASYS AB ABOMINAL DRESSING KIT
SMITH & NEPHEW, INC.              510(k) NO: K112784(SPECIAL)
ATTN: LAURA D REYNOLDS            PHONE NO : 727 329 7702   
970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 22-NOV-11
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINIX-CCI
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K113052(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR.                 SE DECISION MADE: 22-NOV-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEVINE SPINAL SYSTEM
CHANGZHOU ORTHMED MEDICAL INSTRUME510(k) NO: K111690(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 22-NOV-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
DEVILBISS HEALTHCARE LLC          510(k) NO: K112220(TRADITIONAL)
ATTN: JAMES P FROEHLICH           PHONE NO : 814 443 7692   
100 DEVILBISS HEALTHCARE          SE DECISION MADE: 22-NOV-11
SOMERSET PA 15501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRAXION
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K112210(TRADITIONAL)
ATTN: MICHAEL  WOLFF              PHONE NO : 498 232 96920
ROBERT-BOSCH-STRASSE 8            SE DECISION MADE: 22-NOV-11
SCHWABMUNCHEN    GM 86830         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NB3D BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K111944(TRADITIONAL)
ATTN: FLOYD G LARSON              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 22-NOV-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION                510(k) NO: K112760(SPECIAL)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 354 2600   
5960 HEISLEY ROAD                 SE DECISION MADE: 22-NOV-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMIER HB9210 HBA1C ANALYZER
PRIMUS CORPORATION DBA TRINITY BIO510(k) NO: K112015(TRADITIONAL)
ATTN: BRITT  EINSPAHR             PHONE NO : 716 483 7402   
4231 E. 75TH TERRACE              SE DECISION MADE: 22-NOV-11
KANSAS CITY MO 64132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO AORTIC VALVEGUIDE SOFTWARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113027(SPECIAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 484 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 22-NOV-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K113139(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 Almanor Ave                   SE DECISION MADE: 22-NOV-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
WISTRON CORPORATION               510(k) NO: K112647(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F, 5F, NO 127, WUGONG 2ND RD WUGUSE DECISION MADE: 22-NOV-11
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
ACCUMED HEALTHCARE (SHANGHAI) INC.510(k) NO: K112270(ABBREVIATED)
ATTN: CYNTHIA (CINDY)  GREEN      PHONE NO : 425 432 8623   
P.O. BOX 1277                     SE DECISION MADE: 22-NOV-11
MAPLE VALLEY WA 98038             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
ACCUMED HEALTHCARE (SHANGHAI) INC.510(k) NO: K112273(ABBREVIATED)
ATTN: CYNTHIA (CINDY)  GREEN      PHONE NO : 425 765 9509   
P.O. BOX 1277                     SE DECISION MADE: 22-NOV-11
MAPLE VALLEY WA 98038             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMED BLOOD PRESSURE CUFF
UNIMED MEDICAL SUPPLIES INC.      510(k) NO: K112544(TRADITIONAL)
ATTN: XINMEI  TAN                 PHONE NO : 867 552 6695165
NO.37, YANSHAN ROAD, SHEKOU       SE DECISION MADE: 22-NOV-11
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZAVATION SPINAL SYSTEM
ZAVATION LLC                      510(k) NO: K112484(TRADITIONAL)
ATTN: JOHN  WALKER                PHONE NO : 601 919 1119   
501 AVALON WAY                    SE DECISION MADE: 22-NOV-11
BRANDON MS 39047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
WELCH ALLYN, INC.                 510(k) NO: K112687(SPECIAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 22-NOV-11
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K112999(SPECIAL)
ATTN: LORRAINE H PIESTRAK         PHONE NO : 302 631 6279   
P.O. BOX 6101 MIALSTOP 514        SE DECISION MADE: 22-NOV-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INGENUITY TF PET/MR
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K103483(TRADITIONAL)
ATTN: EDUARD  TOEREK              PHONE NO : 440 483 7672   
595 MINER RD.                     SE DECISION MADE: 23-NOV-11
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITALOGRAPH MODEL 7100 - VITALOJAK
VITALOGRAPH(IRELAND) LTD.         510(k) NO: K110525(TRADITIONAL)
ATTN: TOM J HEALY                 PHONE NO : 353 656 864100
ENNIS INDUSTRIAL ESTATE GORT ROAD SE DECISION MADE: 23-NOV-11
ENNIS, CO. CLARE    EI EI         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROM PLUS
CLINICAL INNOVATIONS, LLC         510(k) NO: K110605(TRADITIONAL)
ATTN: DEAN  WALLACE               PHONE NO : 801 268 2800   
747 WEST 4170 SOUTH               SE DECISION MADE: 23-NOV-11
MURRAY UT 84123                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRABECULAR METAL (TM) FUSION DEVICE
ZIMMER SPINE, INC                 510(k) NO: K111119(TRADITIONAL)
ATTN: JENNIFER  TRIBBETT          PHONE NO : 512 533 1061   
12708 RIATA VISTA CIRCLE SUITE B-1SE DECISION MADE: 23-NOV-11
AUSTIN TX 78727                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
BIOKIT S.A.                       510(k) NO: K110619(TRADITIONAL)
ATTN: JOAN  GUIXER                PHONE NO : 349 386 09000
CAN MALE, S/N                     SE DECISION MADE: 23-NOV-11
LLISSA D'AMUNT, BARCELONA    SP 08510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K102644(TRADITIONAL)
ATTN: GERARD  SADRAKULA           PHONE NO : 914 524 2582   
511 BENEDICT AVENUE               SE DECISION MADE: 23-NOV-11
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM AERA AND MAGNETOM SKYRA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111242(TRADITIONAL)
ATTN: MICHELLE L BYRNE            PHONE NO : 610 448 4293   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 23-NOV-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-G5
HAMILTON MEDICAL AG               510(k) NO: K103803(TRADITIONAL)
ATTN: FREDERIKE  BRUEHSCHWEIN     PHONE NO : 41 816 606010
VIA CRUSCH 8                      SE DECISION MADE: 23-NOV-11
BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SDX-4343CS
SAMSUNG MOBILE DISPLAY CO., LTD   510(k) NO: K112751(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LANE              SE DECISION MADE: 23-NOV-11
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAROTID COIL GE 1.5T
TURSIOP TECHNOLOGIES LLC          510(k) NO: K113280(TRADITIONAL)
ATTN: RAJU  VISWANTHAN            PHONE NO : 216 658 4521   
11000 CEDAR AVE., SUITE 280       SE DECISION MADE: 23-NOV-11
CLEVELAND OH 44106                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
JOY LONG                          510(k) NO: K111748(TRADITIONAL)
ATTN: JOY  LONG                   PHONE NO : 317 496 8647   
7750 ZIONSVILLE RD # 850          SE DECISION MADE: 23-NOV-11
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR GLADIATOR HA HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K112150(TRADITIONAL)
ATTN: MATT  PAUL                  PHONE NO : 901 867 4350   
5677 AIRLINE RD.                  SE DECISION MADE: 23-NOV-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOTDOG PATIENT WARMING SYSTEM
AUGUSTINE BIOMEDICAL & DESIGN, LLC510(k) NO: K112488(TRADITIONAL)
ATTN: WENDY  NELSON               PHONE NO : 952 465 3500   
6581 CITY WEST PARKWAY            SE DECISION MADE: 23-NOV-11
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIXIE NEBULIZER
ODYSSEY MEDICAL TECHNOLOGIES      510(k) NO: K112564(TRADITIONAL)
ATTN: DAVID  PIPER                PHONE NO : 916 483 3687   
4807 EL CAMINO AVE, SUITE C       SE DECISION MADE: 23-NOV-11
CARMICHAEL CA 95608               510(k) STATEMENT

DEVICE: PENUMBRA SYSTEM MAX
PENUMBRA, INC.                    510(k) NO: K113163(SPECIAL)
ATTN: SETH  SCHULMAN              PHONE NO : 510 748 3223   
1351 Harbor Bay Parkway           SE DECISION MADE: 23-NOV-11
Alameda CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHT GUIDE CABLE
SCHOTT NORTH AMERICA              510(k) NO: K111342(TRADITIONAL)
ATTN: JEFFREY  ROBERTS            PHONE NO : 508 643 0434   
40 PLAIN STREET                   SE DECISION MADE: 25-NOV-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYTOGUARD(TM) CLOSED LUER CONNECTOR
B. BRAUN MEDICAL, INC.            510(k) NO: K112636(TRADITIONAL)
ATTN: ANGELA J CARAVELLA          PHONE NO : 610 596 2966   
901 MARCON BLVD.                  SE DECISION MADE: 26-NOV-11
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPTOR FACET FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K110170(TRADITIONAL)
ATTN: OLGA  LEWIS                 PHONE NO : 760 494 6717   
5818 EL CAMINO REAL               SE DECISION MADE: 28-NOV-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DP-20 AND DP-30  DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K113153(SPECIAL)
ATTN: SUSAN D GOLDSTEIN           PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 28-NOV-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K111891(SPECIAL)
ATTN: CHRISTOPHER  HACK           PHONE NO : 610 719 6940   
1303 GOSHEN PARKWAY               SE DECISION MADE: 28-NOV-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
NAVILYST MEDICAL, INC.            510(k) NO: K113198(SPECIAL)
ATTN: MARION W GORDON             PHONE NO : 508 949 1129   
26 FOREST STREET                  SE DECISION MADE: 28-NOV-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
BECTON DICKINSON                  510(k) NO: K113241(SPECIAL)
ATTN: KARA  MCKEE                 PHONE NO : 201 847 3247   
1 BECTON DR.                      SE DECISION MADE: 28-NOV-11
FRANKLIN LAKES NJ 07417 1880      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURECORE BIOPSY DEVICE
CHEST INNOVATIONS INC             510(k) NO: K102756(TRADITIONAL)
ATTN: SALMAAN  HAMEED             PHONE NO : 408 826 9740   
827 CANOAS CREEK CIRCLE           SE DECISION MADE: 29-NOV-11
SAN JOSE CA 95136                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNDATION
OLYMPUS TERUMO BIOMATERIALS CORPOR510(k) NO: K111087(TRADITIONAL)
ATTN: PATSY J TRISLER             PHONE NO : 301 652 5344   
5600 WISONSIN AVENUE, #509        SE DECISION MADE: 29-NOV-11
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
RHAUSLER, INC.                    510(k) NO: K111272(ABBREVIATED)
ATTN: BARBARA  DEBIASE            PHONE NO : 303 537 3311   
P.O. BOX 745039                   SE DECISION MADE: 29-NOV-11
ARVADA CO 80006                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
BIOMET MICROFIXATION, INC.        510(k) NO: K111908(TRADITIONAL)
ATTN: KIM  REED                   PHONE NO : 904 741 9443   
1520 TRADEPORT DR.                SE DECISION MADE: 29-NOV-11
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
BIOMERIEUX, INC.                  510(k) NO: K110106(TRADITIONAL)
ATTN: JOLYN  TENLLADO             PHONE NO : 314 731 8386   
595 ANGLUM RD.                    SE DECISION MADE: 30-NOV-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
MEDCOMP (MEDICAL COMPONENTS)      510(k) NO: K110424(TRADITIONAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 30-NOV-11
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DESARA MINI
CALDERA MEDICAL, INC.             510(k) NO: K103418(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 879 6555   
5171 CLARETON DRIVE               SE DECISION MADE: 30-NOV-11
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLAATZ 760
DRTECH CORP.                      510(k) NO: K111655(SPECIAL)
ATTN: CHOUL-WOO  SHIN             PHONE NO : 82 31 7306823
333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 30-NOV-11
SEONGNAM-SHI, GYEONGGI-DO    KS 46510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT TEAR FILM THERMOGRAGH
UNITED INTEGRATED SERVICES CO., LT510(k) NO: K111771(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO.58, FU CHIUN STREET            SE DECISION MADE: 30-NOV-11
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY CARDIO IMAGING
GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K112570(TRADITIONAL)
ATTN: JOHN  MANARIK               PHONE NO : 847 277 5504   
540 W. NW HIGHWAY                 SE DECISION MADE: 30-NOV-11
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530
EIZO NANAO CORPORATION            510(k) NO: K112354(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627 42468
153 SHIMOKASHIWANO,               SE DECISION MADE: 30-NOV-11
HAKUSAN, ISHIKAWA    JA 924-8566  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARGER PTA BALLON DILATATION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K112697(SPECIAL)
ATTN: GLENN  JACQUES              PHONE NO : 763 494 1152   
ONE SCIMED PLACE                  SE DECISION MADE: 30-NOV-11
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALAMO C
ALLIANCE PARTNERS, LLC            510(k) NO: K112361(TRADITIONAL)
ATTN: JENNIFER  PALINCHIK         PHONE NO : 440 933 8850   
33490 PIN OAK PARKWAY             SE DECISION MADE: 30-NOV-11
AVON LAKE OH 44012                510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   244                                     
                                                 TOTAL WITH SUMMARIES        223                                     
                                                 TOTAL WITH STATEMENTS        21