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U.S. Department of Health and Human Services

Medical Devices

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May 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2012
 
 
DEVICE: INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
ALERE SAN DIEGO, INC (FORMALLY BIO510(k) NO: K110212(TRADITIONAL)
ATTN: MARA  CALER                 PHONE NO : 858 805 2083   
9975 SUMMERS RIDGE ROAD           SE DECISION MADE: 01-MAY-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ECHELON OVAL MRI SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K113145(TRADITIONAL)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 01-MAY-12
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXTERNAL FIXATOR ST.A R 90 F4
CITIEFFE                          510(k) NO: K113384(TRADITIONAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD. SUITE 209    SE DECISION MADE: 01-MAY-12
ORMOND BEACH FL 32176             510(k) STATEMENT
 
DEVICE: AYERS ROCK CERVICAL CAGE
QUALGENIX                         510(k) NO: K112801(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203 262 9340   
1 JACK'S HILL ROAD UNIT 3E        SE DECISION MADE: 01-MAY-12
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITAL SIGNS MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K113833(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 01-MAY-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LATERAL FUSION DEVICE
INTEGRA SPINE (INTEGRA LIFESCIENCE510(k) NO: K112986(SPECIAL)
ATTN: DALE  DAVISON               PHONE NO : 330 239 7709   
1153 MEDINA ROAD                  SE DECISION MADE: 01-MAY-12
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PSYCHEMEDICS COCAINE EIA
PSYCHEMEDICS CORP.                510(k) NO: K111925(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 01-MAY-12
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PSYCHEMEDICS OPIATES EIA
PSYCHEMEDICS CORP.                510(k) NO: K111926(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 01-MAY-12
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PSYCHEMEDICS METHAMPHETAMINE EIA
PSYCHEMEDICS CORP.                510(k) NO: K111927(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 01-MAY-12
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PSYCHEMEDICS PHENCYCLIDINE EIA
PSYCHEMEDICS CORP.                510(k) NO: K111928(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 01-MAY-12
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PSYCHEMEDICS CANNABINOIDS EIA
PSYCHEMEDICS CORP.                510(k) NO: K111929(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 01-MAY-12
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MONT BLANC PEDICLE SCREW SYSTEMS
QUALGENIX                         510(k) NO: K112684(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203 982 4239   
1 JACK'S HILL ROAD UNIT 3E        SE DECISION MADE: 01-MAY-12
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
STRYKER CORPORATION               510(k) NO: K112593(TRADITIONAL)
ATTN: MICHELLE  JUMP              PHONE NO : 269 389 7700   
4100 E. MILHAM AVE                SE DECISION MADE: 01-MAY-12
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K121044(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700   
3471 RIVER HILLS DR.              SE DECISION MADE: 01-MAY-12
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPEEDUP SOFTWARE OPTION
ESAOTE, S.P.A.                    510(k) NO: K120748(TRADITIONAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 01-MAY-12
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICROWARE BONE PLATES AND BONE SCREW
MICROWARE PRECISION CO., LTD.     510(k) NO: K111008(SPECIAL)
ATTN: HARRISON  DU                PHONE NO : 866 4 24636275
NO. 12 KEYUAN 2ND RD. SITUN DISTRISE DECISION MADE: 02-MAY-12
TAICHUNG CITY    TW 40763         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ECHOSTAR SPICA 1.5T MR SYSTEM
ALLTECH MEDICAL SYSTEMS AMERICA, I510(k) NO: K113511(TRADITIONAL)
ATTN: MICHAELEEN  DOM             PHONE NO : 440 424 2240   
6551 COCHRAN ROAD                 SE DECISION MADE: 02-MAY-12
SOLON OH 44139                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
RIVERSTONE RESOURCES SDN. BHD.    510(k) NO: K112924(TRADITIONAL)
ATTN: CHONG  CHU MEE              PHONE NO : 603 602 83033
LOT 56, NO. 15, JALAN JASMIN 2    SE DECISION MADE: 02-MAY-12
BUKIT BERUNTUNG, SELANGOR    MY 48510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLASH (DIFFERENT MATERIALS)
3M DEUTSCHLAND GMBH               510(k) NO: K120438(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 02-MAY-12
SEEFELD, BAVARIA    GM D-82229    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZELTIQ COOLSCULPTING
ZELTIQ AESTHETICS, INC.           510(k) NO: K120023(TRADITIONAL)
ATTN: LOUIS-PIERRE  MARCOUX       PHONE NO : 925 474 2500   
4698 Willow Road                  SE DECISION MADE: 02-MAY-12
Pleasanton CA 94588               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POSEY BED
J. T. POSEY CO.                   510(k) NO: K113355(TRADITIONAL)
ATTN: BONNIE  BISHOP              PHONE NO : 626 454 2195   
5635 PECK RD.                     SE DECISION MADE: 02-MAY-12
ARCADIA CA 91006                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JIAJIAN TENS
WUXI JIAJIAN MEDICAL INSTRUMENT CO510(k) NO: K112288(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 862 131 261348
ROOM 1706, NO.128 SONGLE RD SONGJISE DECISION MADE: 02-MAY-12
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
INNERSPACE, INC                   510(k) NO: K113088(TRADITIONAL)
ATTN: DON  BOBO                   PHONE NO : 714 259 7900   
1622 EDINGER AVE STE C            SE DECISION MADE: 02-MAY-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
ENCOMPASS MEDICAL SUPPLIES ONC LIM510(k) NO: K120184(TRADITIONAL)
ATTN: CJ  ANG                     PHONE NO : 006 019 5125422
HUA SHEN ROAD WAI GAO QIAO FREE ZOSE DECISION MADE: 02-MAY-12
SHANGHAI    CH 200131             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
PEROUSE MEDICAL                   510(k) NO: K120261(TRADITIONAL)
ATTN: ISABELLE  JEANTY            PHONE NO : 33 344 081700
Route du Manoir Ivry-le-Temple    SE DECISION MADE: 02-MAY-12
FRANCE    FR 60173                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LULLABY LED PHOTTHERAPY SYSTEM
WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K120168(TRADITIONAL)
ATTN: AGATA  ANTHONY              PHONE NO : 410 456 0239   
8880 GORMAN ROAD                  SE DECISION MADE: 02-MAY-12
LAUREL MD 20723                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
MERETE MEDICAL GMBH               510(k) NO: K120978(SPECIAL)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 493 077 9980114
102 ALT LANKWITZ                  SE DECISION MADE: 02-MAY-12
BERLIN    GM D-12247              510(k) STATEMENT
 
DEVICE: 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
MEDICAL COMPONENTS INC            510(k) NO: K120980(SPECIAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 02-MAY-12
HARLEYSVILLE PA 19438             510(k) STATEMENT
 
DEVICE: 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
MEDICAL COMPONENTS INC            510(k) NO: K120981(SPECIAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 02-MAY-12
HARLEYSVILLE PA 19438             510(k) STATEMENT
 
DEVICE: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K120983(SPECIAL)
ATTN: JANIS F TARANTO             PHONE NO : 508 683 4560   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 02-MAY-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCUMESH DEPLOYMENT SYSTEM
COVIDIEN LLC                      510(k) NO: K121139(SPECIAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
15 CROSBY DR                      SE DECISION MADE: 02-MAY-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAIRE COMPANION 5 OXYGEN CONCENTRATOR
CAIRE INC.                        510(k) NO: K121167(TRADITIONAL)
ATTN: BEN  KADRLIK                PHONE NO : 770 721 7730   
2200 AIRPORT INDUSTRIAL DRIVE SUITSE DECISION MADE: 02-MAY-12
BALL GROUND GA 30107              510(k) STATEMENT
                                  THIRD PARTY REVIEW
 
DEVICE: ES FLOW
SPIDENT CO., LTD.                 510(k) NO: K120768(TRADITIONAL)
ATTN: I.S.  WHANG                 PHONE NO : 823 281 94570
312, 151B-6L NAMDONGGONGDAN       SE DECISION MADE: 03-MAY-12
INCHEON    KS 405-821             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
CRYOTHERAPY PRODUCTS INC.         510(k) NO: K113660(TRADITIONAL)
ATTN: JORGE  CABALLERO            PHONE NO : 305 395 4532   
1804 SW 81                        SE DECISION MADE: 03-MAY-12
TERRACE DAVIE FL 33324            510(k) STATEMENT
 
DEVICE: RAPIDPOINT 500 BLOOD GAS ANALYER
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K113216(TRADITIONAL)
ATTN: STEVEN  GOLDBERG            PHONE NO : 781 269 3941   
2 EDGEWATER DRIVE                 SE DECISION MADE: 03-MAY-12
NORWOOD MA 02062                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ATAL-8
ATLAIM                            510(k) NO: K113812(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 244 1735   
81 SEACOUNTRY LANE                SE DECISION MADE: 03-MAY-12
RANCHO SANTA MARGARITA CA 92688   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORCE MEDICAL IM NAIL SYSTEM
FORCE MEDICAL, INC                510(k) NO: K102577(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH ST.                 SE DECISION MADE: 03-MAY-12
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
I-SENS, INC.                      510(k) NO: K120351(SPECIAL)
ATTN: HYUN  JOON OH               PHONE NO : 822 916 6191
465-6 WOLGYE4-DONG, NOWON-GU      SE DECISION MADE: 03-MAY-12
SEOUL    KR 139-845               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
 INTL., INC.                510(k) NO: K112083(TRADITIONAL)
ATTN: MICHAEL D CECCHI            PHONE NO : 203 453 1700   
393 SOUNDVIEW RD.                 SE DECISION MADE: 03-MAY-12
GUILFORD CT 06437                 510(k) STATEMENT
 
DEVICE: GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K113341(ABBREVIATED)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 03-MAY-12
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GEM PREMIER 4000
INSTRUMENTATION LABORATORY CO.    510(k) NO: K112995(TRADITIONAL)
ATTN: CARL  MARBLE                PHONE NO : 781 861 4467   
180 Hartwell Rd.                  SE DECISION MADE: 03-MAY-12
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HALO90 ULTRA ABLATION CATHETER
BARRX MEDICAL, INC.               510(k) NO: K120431(TRADITIONAL)
ATTN: DAWN  CHANG                 PHONE NO : 408 328 7357   
540 OAKMEAD PARKWAY               SE DECISION MADE: 03-MAY-12
Sunnyvale CA 94085                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EMBRACE THERMOPLASTIC
BIONIX DEVELOPMENT CORP.          510(k) NO: K120335(TRADITIONAL)
ATTN: JAMES  HUTTNER M.D., PH.D.  PHONE NO : 419 727 8421   
5154 ENTERPRISE BLVD.             SE DECISION MADE: 03-MAY-12
TOLEDO OH 43612                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
RADIADYNE, LLC (SPECIFICATION DEVE510(k) NO: K120344(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 281 759 9600   
11931 WICKCHESTER LANE            SE DECISION MADE: 03-MAY-12
HOUSTON TX 77043                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHOLOC 3DI HALLUX SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K120359(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 03-MAY-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIPER SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K121020(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DR.                 SE DECISION MADE: 03-MAY-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDO CLIP III 5MM CLIP APPLIER
COVIDIEN                          510(k) NO: K121194(SPECIAL)
ATTN: ANGELA VAN  ARSDALE         PHONE NO : 203 492 5496   
60 MIDDLETOWN AVE.                SE DECISION MADE: 03-MAY-12
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
ST. JUDE MEDICAL                  510(k) NO: K121006(SPECIAL)
ATTN: NICOLE  MARWICK             PHONE NO : 651 756 5162   
14901 DEVEAU PL.                  SE DECISION MADE: 03-MAY-12
MINNETONKA MN 55345 2126          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LOSPA TIBIAL BASE PLATE
CORENTEC CO., LTD                 510(k) NO: K121037(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 820 743933 819
11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 03-MAY-12
SEOCHO GU, SEOUL    KS 137-040    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APTIMA COMBO 2 ASSAY
GEN-PROBE, INC.                   510(k) NO: K111409(TRADITIONAL)
ATTN: JODY J FLEMING              PHONE NO : 858 410 8634   
10210 GENETIC CENTER DR.          SE DECISION MADE: 03-MAY-12
SAN DIEGO CA 92121 4362           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIALOK NON-VENTED
YUKON MEDICAL, LLC                510(k) NO: K121182(TRADITIONAL)
ATTN: CARL  DUPPER                PHONE NO : 919 595 8257   
4819-400 EMPEROR BLVD             SE DECISION MADE: 03-MAY-12
DURHAM NC 27703                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
3M COMPANY                        510(k) NO: K120704(TRADITIONAL)
ATTN: JON  PLATT                  PHONE NO : 651 736 1850   
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 03-MAY-12
ST. PAUL MN 55133 3275            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
COVALON TECHNOLOGIES, INC.        510(k) NO: K112549(TRADITIONAL)
ATTN: KIM  CROOKS                 PHONE NO : 905 568 8400
405 BRITANNIA RD. EAST SUITE 106  SE DECISION MADE: 04-MAY-12
MISSISSAUGA, ONTARIO    CA L4Z 3E6510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUANTUM DENTAL IMPLANT SYSTEM
QUANTUM BIOENGINEERING, LTD.      510(k) NO: K112279(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 04-MAY-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DUKAL LUBRICATING JELLY
DUKAL CORPORATION                 510(k) NO: K113689(TRADITIONAL)
ATTN: PATRICK J LAMB              PHONE NO : 631 656 3800   
2 FLEETWOOD CT                    SE DECISION MADE: 04-MAY-12
RONKONKOMA NY 11779               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIVIX-S
VIEWORKS CO., LTD.                510(k) NO: K120020(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST UNIT J            SE DECISION MADE: 04-MAY-12
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STERILCONTAINER SYSTEM
AESCULAP, LTD.                    510(k) NO: K112671(SPECIAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076   
3773 CORPORATE PARKWAY            SE DECISION MADE: 04-MAY-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
CORDIS CORP.                      510(k) NO: K112797(TRADITIONAL)
ATTN: DANNA  MARSHALL             PHONE NO : 908 541 4781   
430 ROUTE 22 EAST                 SE DECISION MADE: 04-MAY-12
BRIDGEWATER NJ 08807              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KIMBERLY-CLARK CHILD'S FACEMASK
KIMBERLY-CLARK                    510(k) NO: K113340(TRADITIONAL)
ATTN: ANN  WATERHOUSE             PHONE NO : 678 352 6719   
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 04-MAY-12
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCUSONIC ADVANTAGE
METRON MEDICAL AUSTRALIA PTY LTD  510(k) NO: K120171(SPECIAL)
ATTN: DAVID  MITCHELL             PHONE NO : 613 977 51234
57 ASTER AVE.                     SE DECISION MADE: 04-MAY-12
CARRUM DOWNS    AS 3201           510(k) STATEMENT
 
DEVICE: KENSEY NASH BONE VOID FILLER XC
KENSEY NASH CORORATION            510(k) NO: K120141(TRADITIONAL)
ATTN: SUSAN  PILEGGI              PHONE NO : 484 713 2100   
735 PENNSYLVANIA DRIVE            SE DECISION MADE: 04-MAY-12
EXTON PA 19464                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
J. MORITA USA, INC.               510(k) NO: K112665(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET NW SUITE 1100       SE DECISION MADE: 04-MAY-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
CORIN U.S.A.                      510(k) NO: K120362(TRADITIONAL)
ATTN: LUCINDA  GERBER, BA (HONS)  PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 04-MAY-12
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNIMED DISPOSABLE BLOOD PRESSURE CUFF
UNIMED MEDICAL SUPPLIES INC.      510(k) NO: K120364(TRADITIONAL)
ATTN: XINMEI  TAN                 PHONE NO : 867 552 6695165
NO.37, YANSHAN ROAD, SHEKOU       SE DECISION MADE: 04-MAY-12
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
WILLIAM COOK EUROPE APS           510(k) NO: K121057(SPECIAL)
ATTN: JENNIFER  BROWN             PHONE NO : 765 463 7537   
ONE GEDDES WAY                    SE DECISION MADE: 04-MAY-12
WEST LAFAYETTE IN 47906           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
ABBOTT VASCULAR                   510(k) NO: K121015(SPECIAL)
ATTN: IVALEE  COHEN               PHONE NO : 408 845 0682   
3200 LAKESIDE DRIVE               SE DECISION MADE: 04-MAY-12
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HLIC NEEDLE-LESS VALVE
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K120548(TRADITIONAL)
ATTN: NOLA  BENSTOG               PHONE NO : 801 773 7798   
803 N. 1250 W. SUITE 1            SE DECISION MADE: 04-MAY-12
CENTERVILLE UT 84014              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: END TIDAL CO2 NASAL CANNULA
CAREFUSION                        510(k) NO: K120518(TRADITIONAL)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 473 7208   
1500 WAUKEGAN ROAD                SE DECISION MADE: 04-MAY-12
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: "UNITED" U2 FEMORAL COMPONENT, PS, #7
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K120507(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 04-MAY-12
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K112790(TRADITIONAL)
ATTN: KAREN  HILL                 PHONE NO : 44 138 2422000
THE TECHNOLOGY PARK LUNA PLACE    SE DECISION MADE: 07-MAY-12
DUNDEE,    UK DD2 1XA             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GEN_2 MECHANICAL WHEELCHAIR
FREE WHEELCHAIR MISSION           510(k) NO: K113713(TRADITIONAL)
ATTN: SHARON  ROCKWELL            PHONE NO : 714 695 9269   
5582 CHALON ROAD                  SE DECISION MADE: 07-MAY-12
YORBA LINDA CA 92886              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
APIXIA INC.                       510(k) NO: K120106(TRADITIONAL)
ATTN: ERIC  HUANG                 PHONE NO : 626 810 9201   
18688 SAN JOSE AVE.               SE DECISION MADE: 07-MAY-12
INDUSTRY CA 91748                 510(k) STATEMENT
 
DEVICE: IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
BRAINLAB AG                       510(k) NO: K113732(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 07-MAY-12
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
BIOSENSE WEBSTER, INC.            510(k) NO: K120550(TRADITIONAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD            SE DECISION MADE: 07-MAY-12
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PIONEER LATERAL PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K120724(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 07-MAY-12
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPHIRA MINI SLING SYSTEM
PROMEDON S.A.                     510(k) NO: K110420(TRADITIONAL)
ATTN: STEPHANIE  RAIS             PHONE NO : 732 885 3955   
221 ELLIS PARKWAY                 SE DECISION MADE: 08-MAY-12
PISCATAWAY NJ 08854               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
PANTEX, DIV. BIO-ANALYSIS, INC.   510(k) NO: K102841(TRADITIONAL)
ATTN: ROMULO  GARZA               PHONE NO : 310 828 7423   
1701 BERKELEY ST.                 SE DECISION MADE: 08-MAY-12
SANTA MONICA CA 90404             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANDOX COCAINE METABOLITE
RANDOX LABORATORIES, LTD.         510(k) NO: K113751(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 08-MAY-12
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) STATEMENT
 
DEVICE: VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K120072(TRADITIONAL)
ATTN: KAREN  JONES                PHONE NO : 801 565 6231   
12050 LONE PEAK PKWY              SE DECISION MADE: 08-MAY-12
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
MERITS HEALTH PRODUCTS CO., LTD.  510(k) NO: K113577(TRADITIONAL)
ATTN: STEVE  CHAO                 PHONE NO : 886 423 594985
NO.18 JINGKE RD. NANTUN DIST      SE DECISION MADE: 08-MAY-12
TAICHUNG    TW 40852              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMSCO CHIMERON MEDIUM STEAM STERLILZER
STERIS CORPORATION                510(k) NO: K112403(ABBREVIATED)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 08-MAY-12
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
NIDEK TECHNOLOGIES SRL            510(k) NO: K113451(TRADITIONAL)
ATTN: ENRICO  BISSON              PHONE NO : 390 498 629200
VIA DELL ARTIGIANATO, 6/A         SE DECISION MADE: 08-MAY-12
ALBIGNASEGO (PADOVA)    IT 35020  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: C2 MEDICAL GLOVES
AMERCARE, INC.                    510(k) NO: K113639(TRADITIONAL)
ATTN: ANDREW  LOWERY              PHONE NO : 410 592 9175   
611 W. 5TH STREET THIRD FLOOR     SE DECISION MADE: 08-MAY-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K113670(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 08-MAY-12
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RELIANCE CERVICAL IBF SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K120396(TRADITIONAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280   
545 SOUTH 500 WEST SUITE 100      SE DECISION MADE: 08-MAY-12
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: G+ SYSTEM
GLYTEC, LLC                       510(k) NO: K113853(TRADITIONAL)
ATTN: WILLIAM  MATTHEWS           PHONE NO : 864 370 3297   
665 N. ACADEMY ST.                SE DECISION MADE: 08-MAY-12
GREENVILLE SC 29601               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PERFORMER HT/ HANG&GO HT BASIC
RAND S.R.L.                       510(k) NO: K120026(TRADITIONAL)
ATTN: SIMONE  CERETTI             PHONE NO : 390 535 49283
VIA STATALE 12,62                 SE DECISION MADE: 08-MAY-12
MEDOLLA, (MO)    IT 41036         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
SHANDONG ZHIYUAN MEDICAL PRODUCTS 510(k) NO: K112266(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVENUE             SE DECISION MADE: 08-MAY-12
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VEIN-GOGH INSTRUMENT
REFINE USA, LLC                   510(k) NO: K112334(TRADITIONAL)
ATTN: BRIAN  SMITH                PHONE NO : 904 626 0100   
340 3RD AVENUE SOUTH SUITE C      SE DECISION MADE: 08-MAY-12
JACKSONVILLE BEACH FL 32250       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIFESTYLES ZERO LUBRICATED LATEX CONDOM
ANSELL HEATHCARE PRODUCTS LLC     510(k) NO: K120394(ABBREVIATED)
ATTN: CYNTHIA  INGRAM             PHONE NO : 334 615 2563   
1635 INDUSTRIAL ROAD              SE DECISION MADE: 08-MAY-12
DOTHAN AL 36303                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COBES SURGICAL DRAPE
COBES INDUSTRIES CO., LTD.        510(k) NO: K112378(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 08-MAY-12
DOVER DE 19901                    510(k) STATEMENT
 
DEVICE: SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
SAKURA SEIKI CO., LTD.            510(k) NO: K120149(TRADITIONAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 843 1675   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 08-MAY-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K120298(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 493 2960   
15900 VALLEY VIEW CT.             SE DECISION MADE: 08-MAY-12
SYLMAR CA 91342                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CALCIUM GEN. 2
ROCHE DIAGNOSTICS                 510(k) NO: K113521(TRADITIONAL)
ATTN: LISA K KLINEDINST           PHONE NO : 317 521 1942   
9115 HAGUE ROAD                   SE DECISION MADE: 08-MAY-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNAPSE 3D BRAIN PERFUSION
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K120637(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 08-MAY-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GLOW BY ENDYMED
ENDYMED MEDICAL LTD               510(k) NO: K120513(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 08-MAY-12
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K120761(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 ALMANOR AVE                   SE DECISION MADE: 08-MAY-12
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LATEX EXAMINATION GLOVES (POWDERED)
TOP CALIBRE SDN BHD               510(k) NO: K120693(TRADITIONAL)
ATTN: TRACY  NGUI                 PHONE NO : 603 329 10516
1-1,2 JALAN SETIA PRIMA U13/S SETISE DECISION MADE: 08-MAY-12
SHAH ALAM    MY 40170             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TERUMO PALL AL20X ARTERIAL FILTER
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K121209(SPECIAL)
ATTN: SUZANNE  GRENIER            PHONE NO : 800 262 3304   
125 BLUE BALL RD.                 SE DECISION MADE: 08-MAY-12
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PLATEAU SPACER SYSTEM
LIFE SPINE                        510(k) NO: K121116(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 Hassell Rd Ste 1535          SE DECISION MADE: 08-MAY-12
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOMATOM DEFINITION FLASH
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K121072(SPECIAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 08-MAY-12
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K121166(SPECIAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE SUITE F      SE DECISION MADE: 08-MAY-12
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
SYNTHES USA                       510(k) NO: K120717(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PKWY                  SE DECISION MADE: 08-MAY-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFU BOX TYPE 0412A
MEDICAL RESCUE EQUIPMENT HOLDING A510(k) NO: K120860(TRADITIONAL)
ATTN: KNUT  FANGBERGET            PHONE NO : 004 790 610425
POSTBOKS 186                      SE DECISION MADE: 08-MAY-12
Porsgrunn    NO 3901              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DSS STABILIZATION SYSTEM-RIGID
PARADIGM SPINE, LLC               510(k) NO: K120491(TRADITIONAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 09-MAY-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
BM KOREA CO., LTD.                510(k) NO: K120353(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 09-MAY-12
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K121084(ABBREVIATED)
ATTN: FRANCES A DILLON            PHONE NO : 302 631 6951   
PO BOX 6101 MAILSTOP 514          SE DECISION MADE: 09-MAY-12
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COMPLETE D 25-OH VITAMIN D CONTROL
QUANTIMETRIX CORP.                510(k) NO: K113177(TRADITIONAL)
ATTN: KALYNA  SNYLYK              PHONE NO : 310 536 0006   
2005 MANHATTAN BEACH BLVD.        SE DECISION MADE: 10-MAY-12
REDONDO BEACH CA 90278 1205       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARRW EVOLUTION
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K112896(TRADITIONAL)
ATTN: TRACY  MADDOCK              PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 10-MAY-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ILWAIT TIMER OCULOPRESSOR
ORYX MEDICAL PTY LTD              510(k) NO: K112952(TRADITIONAL)
ATTN: ANNE F JONES                PHONE NO : 617 544 90087
UNIT 4/43 CALEDONIAN AVENUE       SE DECISION MADE: 10-MAY-12
MAYLANDS    AU 6051               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K120369(TRADITIONAL)
ATTN: BUNICHIRO  NAKAJIMA         PHONE NO : 650 961 5501   
630 CLYDE CT.                     SE DECISION MADE: 10-MAY-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SENTRYSUITE PRODUCT LINE
CAREFUSION GERMANY 234 GMBH       510(k) NO: K113813(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 10-MAY-12
HOECHBERG    GM 97204             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LUCINA-MELODI
GENADYNE BIOTECHNOLOGIES, INC.    510(k) NO: K112856(TRADITIONAL)
ATTN: CHIEN-MING  GOH             PHONE NO : 800 208 2025   
16 MIDLAND AVE                    SE DECISION MADE: 10-MAY-12
HICKSVILLE NY 11801               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
LIMACORPORATE S.P.A.              510(k) NO: K112158(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 10-MAY-12
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POCKETCPR
ZOLL MEDICAL CORP.                510(k) NO: K112660(ABBREVIATED)
ATTN: ROBERT  MORSE               PHONE NO : 866 639 0060   
525 NARRAGANSETT PARK DRIVE       SE DECISION MADE: 10-MAY-12
PAWTUCKET RI 02861                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EOS SMALL BONE FIXATION SYSTEM
TRIMED, INC.                      510(k) NO: K112794(TRADITIONAL)
ATTN: DOUG  STEINBERGER           PHONE NO : 661 255 7406   
27533 AVENUE HOPKINS              SE DECISION MADE: 10-MAY-12
SANTA CLARITA CA 91355            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERTESSA
CALDERA MEDICAL, INC.             510(k) NO: K120327(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 483 7602   
5171 CLARETON DRIVE               SE DECISION MADE: 10-MAY-12
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GC BLUE SILICONE
GC AMERICA, INC.                  510(k) NO: K120521(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 926 3090   
3737 WEST 127TH ST.               SE DECISION MADE: 10-MAY-12
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUAMANTYS3 9.5 XL BIPOLAR SEALER
MEDTRONIC INC.                    510(k) NO: K120537(SPECIAL)
ATTN: TARA N TURNEY, RAC          PHONE NO : 603 742 5445   
180 INTERNATIONAL DR              SE DECISION MADE: 10-MAY-12
PORTSMOUTH NH 03801               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EZSENSOR P DIGITAL INTRAORAL SENSOR
HUMANRAY CO,LTD                   510(k) NO: K121132(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 10-MAY-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECSYS LH CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K121279(TRADITIONAL)
ATTN: K. COLLEEN  ADAMS           PHONE NO : 317 521 3577   
9115 HAGUE ROAD                   SE DECISION MADE: 10-MAY-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DOBBHOFF DUAL PORT FEEDING TUBE
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K112511(TRADITIONAL)
ATTN: DEBORA  STAPLETON           PHONE NO : 508 452 4866   
15 HAMPSHIRE ST.                  SE DECISION MADE: 11-MAY-12
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KIMBERLY-CLARK  KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
KIMBERLY-CLARK CORPORATION        510(k) NO: K113333(TRADITIONAL)
ATTN: MARCIA  JOHNSON             PHONE NO : 770 587 8566   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 11-MAY-12
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K120185(TRADITIONAL)
ATTN: BARRY  SALL                 PHONE NO : 781 424 4742   
195 WEST STREET                   SE DECISION MADE: 11-MAY-12
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUNMED GUIDE WIRE
SUNNY MEDICAL DEVICE (SHENZHEN) CO510(k) NO: K120119(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949 262 0411   
3722 AVE. SAUSALITO               SE DECISION MADE: 11-MAY-12
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
BIOPTIGEN, INC.                   510(k) NO: K120057(TRADITIONAL)
ATTN: DAWN  REILLY-O'DELL         PHONE NO : 919 410 7497   
104 T.W. ALEXANDER DRIVE P.O. BOX SE DECISION MADE: 11-MAY-12
DURHAM NC 27709                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEALIX ADVANCE PEEK ANCHOR
DEPUY MITEK SARL, A JOHNSON AND JO510(k) NO: K120449(TRADITIONAL)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828 3541   
325 PARAMOUNT DRIVE               SE DECISION MADE: 11-MAY-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
BROADMASTER BIOTECH CORPERATION   510(k) NO: K120183(SPECIAL)
ATTN: ROGER  LAI                  PHONE NO : 886 266 375859
7F, NO. 168-2, LIANCHENG RD.      SE DECISION MADE: 11-MAY-12
ZHONGHE DIST    TW 23553          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TATTOOSTAR EFFECT Y
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K112669(TRADITIONAL)
ATTN: ANTJE  KATZER               PHONE NO : 493 641 7700309
BRUESSELER STR. 10                SE DECISION MADE: 11-MAY-12
JENA    GM 07747                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
CHURCH & DWIGHT VIRGINIA CO., INC.510(k) NO: K120249(TRADITIONAL)
ATTN: JOSEPH  CICCONE             PHONE NO : 609 497 7251   
469 NORTH HARRISON STREET         SE DECISION MADE: 11-MAY-12
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K120296(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 493 2960   
15900 VALLEY VIEW CT.             SE DECISION MADE: 11-MAY-12
SYLMAR CA 91342                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
MISDER, LLC                       510(k) NO: K120821(TRADITIONAL)
ATTN: NANCY  SAUER                PHONE NO : 303 526 7402   
433 PARK POINT DRIVE SUITE 140    SE DECISION MADE: 11-MAY-12
GOLDEN CO 80401                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
CYNOSURE, INC.                    510(k) NO: K121127(SPECIAL)
ATTN: IRINA  KULINETS             PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 13-MAY-12
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ROCAMED ROCAUS PLATINUM
PROMEPLA SAM                      510(k) NO: K120160(TRADITIONAL)
ATTN: KRISTA  JOHNSON             PHONE NO : 377 979 84193
LE COPORI-9 AVENUE PRINCE ALBERT ISE DECISION MADE: 14-MAY-12
MONACO    MN MC 9800              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
ROCHE DIAGNOSTICS                 510(k) NO: K111188(TRADITIONAL)
ATTN: SARAH  BAUMANN              PHONE NO : 317 521 3952   
9115 HAGUE RD.                    SE DECISION MADE: 14-MAY-12
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COMED K-SERIES MANUAL WHEELCHAIR
DANYANG COMED HEALTHCARE CO., LTD 510(k) NO: K120077(TRADITIONAL)
ATTN: RHONDA  ALEXANDER           PHONE NO : 757 224 0177   
144 RESEARCH DRIVE                SE DECISION MADE: 14-MAY-12
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113194(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 14-MAY-12
CHU XIAOAN    CH 100083           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
NONIN MEDICAL, INC.               510(k) NO: K113215(TRADITIONAL)
ATTN: BRODIE  PEDERSON            PHONE NO : 763 577 3180   
13700 1ST AVE, NORTH              SE DECISION MADE: 14-MAY-12
Plymouth MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MLS, ZERONA-AD
ERCHONIA MEDICAL, INC.            510(k) NO: K120257(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT             SE DECISION MADE: 14-MAY-12
GREENWOOD VILLAGE CO 80127        510(k) STATEMENT
 
DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
WON INDUSTRIAL CO.                510(k) NO: K120166(TRADITIONAL)
ATTN: DANIEL  NAM                 PHONE NO : 213 626 1544   
4568 W. 1ST, STE 104              SE DECISION MADE: 14-MAY-12
LOS ANGELES CA 90004              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TINA-QUANT ALBUMIN GEN.2
ROCHE DIAGNOSTICS OPERATIONS      510(k) NO: K113072(TRADITIONAL)
ATTN: PATRICK  STIMART            PHONE NO : 317 521 3954   
9115 Hague Rd                     SE DECISION MADE: 14-MAY-12
Indianapolis IN 46256             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GEL-BLOCK EMBOLIZATION PLEDGETS
VASCULAR SOLUTIONS, INC.          510(k) NO: K113266(TRADITIONAL)
ATTN: JENNIFER  RUETHER           PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 14-MAY-12
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
CANOPUS MEDICAL SUPPLY CO., LTD.  510(k) NO: K120798(ABBREVIATED)
ATTN: GLORIA  CHANG               PHONE NO : 909 465 9188   
18709 GREEN BAT DR.,              SE DECISION MADE: 14-MAY-12
ROWLAND HIGHS CA 91748            510(k) STATEMENT
 
DEVICE: LATEX EXAMINATION GLOVES (POWDER FREE)
TOP CALIBRE SDN BHD               510(k) NO: K120692(TRADITIONAL)
ATTN: TRACY  NGUI                 PHONE NO : 603 329 10516
1-1,2 JALAN SETIA PRIMA U13/S SETISE DECISION MADE: 14-MAY-12
SHAH ALAM    MY 40170             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
MEDICA CORP.                      510(k) NO: K120497(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 14-MAY-12
BEDFORD MA 01730                  510(k) STATEMENT
 
DEVICE: SR PHONARES II
IVOCLAR VIVADENT AG               510(k) NO: K120736(TRADITIONAL)
ATTN: DONNA M HARTNETT            PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 14-MAY-12
AMHERST NY 14228                  510(k) STATEMENT
 
DEVICE: SYNTHES USS CONNECTOR
SYNTHES SPINE                     510(k) NO: K120571(TRADITIONAL)
ATTN: HEMAL  MEHTA                PHONE NO : 610 719 5424   
1302 WRIGHTS LN EAST              SE DECISION MADE: 14-MAY-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FILMARRAY RP PANEL
IDAHO TECHNOLOGY, INC.            510(k) NO: K120267(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 15-MAY-12
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S 100 PEDICLE SCREW SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K111940(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 15-MAY-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVIA CHEMISTRY GLUH_3 REAGENTS
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K120681(TRADITIONAL)
ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   
511 BENEDICT AVENUE               SE DECISION MADE: 15-MAY-12
TARRYTOWN NY 10509                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QLAB WITH FHN AND VPQ PLUG-IN
PHILIPS ULTRASOUND, INC.          510(k) NO: K121223(TRADITIONAL)
ATTN: PENNY  GRECO                PHONE NO : 978 659 4615   
3000 MINUTEMAN RD.                SE DECISION MADE: 15-MAY-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
TENSYS MEDICAL SYSTEMS, INC       510(k) NO: K121141(SPECIAL)
ATTN: JAMIE  SULLEY               PHONE NO : 858 320 3234   
5825 OBERLIN DRIVE SUITE 100      SE DECISION MADE: 15-MAY-12
SAN DIEGO CA 92121                510(k) STATEMENT
 
DEVICE: SWITCH-IT CATHETER
VASCULAR SOLUTIONS, INC.          510(k) NO: K120707(TRADITIONAL)
ATTN: ELLIE  GILLESPIE            PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 15-MAY-12
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
TELEFLEX, INC.                    510(k) NO: K103658(TRADITIONAL)
ATTN: PAUL  AMUDALA               PHONE NO : 610 378 0131   
2400 BERNVILLE ROAD               SE DECISION MADE: 16-MAY-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K112127(TRADITIONAL)
ATTN: TERRY  MCMAHON              PHONE NO : 727 399 3785   
970 LAKE CARILLON DR. SUITE 110   SE DECISION MADE: 16-MAY-12
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
MEDICAL.GORITHMICS S.A.           510(k) NO: K112921(ABBREVIATED)
ATTN: MARTIN  JASINSKI            PHONE NO : 917 941 9581   
245 WEST 107TH ST. SUITE 11A      SE DECISION MADE: 16-MAY-12
NEW YORK NY 10025                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARPATH UPPER GI
EASYGLIDE LTD.                    510(k) NO: K113166(SPECIAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 16-MAY-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
CHURCH & DWIGHT CO., INC.         510(k) NO: K120287(TRADITIONAL)
ATTN: JOSEPH  CICCONE             PHONE NO : 609 497 7251   
469 NORTH HARRISON STREET         SE DECISION MADE: 16-MAY-12
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
APEX MEDICAL CORP.                510(k) NO: K120035(SPECIAL)
ATTN: ALAN  CHANG                 PHONE NO : 866 2 22685568
NO. 9, MINSHENG STREET            SE DECISION MADE: 16-MAY-12
TUCHENG CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PATIENT MONITOR
EDAN INSTRUMENTS INC              510(k) NO: K120173(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6856469
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 16-MAY-12
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARAYA AR , VARAYA SPORT
VARAYA PHOTOCEUTICALS, LLC        510(k) NO: K112494(TRADITIONAL)
ATTN: MYK  LUM                    PHONE NO : 949 753 1482   
16511 SCIENTIFIC WAY SUITE 200    SE DECISION MADE: 16-MAY-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARPATH LOWER GI
EASYGLIDE LTD.                    510(k) NO: K113050(SPECIAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 16-MAY-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENOSYL MV-1000
GENO LLC                          510(k) NO: K120216(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
2941 OXBOW CIRCLE                 SE DECISION MADE: 16-MAY-12
COCOA FL 32926                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VANGUARD SSK 360 REVISION KNEE SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K121149(SPECIAL)
ATTN: GARY  BAKER, M.S. RAC       PHONE NO : 574 267 6639   
56 EAST BELL DRIVE                SE DECISION MADE: 16-MAY-12
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARTHREX MIXING AND DELIVERY SYSTEM
ARTHREX, INC.                     510(k) NO: K121124(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 16-MAY-12
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
BOSTON SCIENTIFIC CORP.           510(k) NO: K121186(SPECIAL)
ATTN: CORRIE  GOODING             PHONE NO : 508 683 6643   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 16-MAY-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MRI SYTEMS
SHENZHEN ANKE HIGH-TECH CO., LTD. 510(k) NO: K113281(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 17-MAY-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TISSUE OF ORIGIN TEST KIT FFPE
PATHWORK DIAGNOSTICS, INC.        510(k) NO: K120489(TRADITIONAL)
ATTN: ANNA  LONGWELL              PHONE NO : 650 213 9162   
1900 EMBARCADERO ROAD             SE DECISION MADE: 17-MAY-12
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MINI CANNULATED HEADED AND HEADLESS SCREW SET
INSTRATEK, INC.                   510(k) NO: K120493(TRADITIONAL)
ATTN: JEFF  SEAVEY                PHONE NO : 281 890 8020   
4141 Directors Row Ste H          SE DECISION MADE: 17-MAY-12
Houston TX 77092                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113253(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 17-MAY-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESTORELLE POLYPROPYLENE Y MESH
COLOPLAST A/S                     510(k) NO: K112322(TRADITIONAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER ROAD N            SE DECISION MADE: 17-MAY-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRESTO BREAST BIOPSY DEVICE
SONTINA MEDICAL, LLC              510(k) NO: K120440(TRADITIONAL)
ATTN: ROBERT  PELIKS              PHONE NO : 415 873 3831   
111 SUTRO HEIGHTS AVENUE          SE DECISION MADE: 17-MAY-12
SAN FRANCISCO CA 94121            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIQUID BANDAGE
CHESSON LABORATORY ASSOCIATES, INC510(k) NO: K120059(TRADITIONAL)
ATTN: SCOTT E NEUVILLE            PHONE NO : 919 957 1797   
603 ELLIS ROAD                    SE DECISION MADE: 17-MAY-12
DURHAM NC 27703                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEARTCHECK ECG PEN WITH GEMS HOME
CARDIO COMM SOLUTIONS, INC.       510(k) NO: K121009(TRADITIONAL)
ATTN: JONATHAN  WARD              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 17-MAY-12
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
ETHICON ENDO-SURGERY, LLC         510(k) NO: K120729(TRADITIONAL)
ATTN: DONOVAN  MAY                PHONE NO : 513 337 7981   
4545 CREEK ROAD                   SE DECISION MADE: 17-MAY-12
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LONG LIFE PADTM
OMRON HEALTHCARE, INC.            510(k) NO: K120516(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 17-MAY-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
CHEMTRON BIOTECH, INC.            510(k) NO: K121339(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 Juniper Creek Ln Ste 1-2     SE DECISION MADE: 17-MAY-12
San Diego CA 92126                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTION          510(k) NO: K121138(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
1230 SHOREBIRD WAY                SE DECISION MADE: 17-MAY-12
MOUNTAINVIEW CA 94043             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ARCHITECT B12
ABBOTT LABORATORIES               510(k) NO: K121314(TRADITIONAL)
ATTN: DARLA A ABANO               PHONE NO : 847 937 3461   
100 ABBOTT PARK ROAD DEPT. 09V6 APSE DECISION MADE: 17-MAY-12
ABBOTT PARK IL 60064              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HAYMAX
HAYMAX LIMITED                    510(k) NO: K120894(TRADITIONAL)
ATTN: MAX  WISEBERG               PHONE NO : 441 525 406600
POSTERN PIECE FARM BEDFORD STREET SE DECISION MADE: 17-MAY-12
AMPTHILL, BEDFORDSHIRE    UK MK45 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XPRESS MULTI-SINUS DILATION TOOL
ENTELLUS MEDICAL, INC.            510(k) NO: K121174(SPECIAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 17-MAY-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVOLUTION COLONIC STENT SYSTEM
COOK IRELAND LTD                  510(k) NO: K113510(TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 011 353 61334440
O'HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 17-MAY-12
LIMERICK    EI EI                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K113565(SPECIAL)
ATTN: MARGUEITE  THOMLINSON       PHONE NO : 949 756 7386   
ONE EDWARDS WAY                   SE DECISION MADE: 18-MAY-12
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
ETVIEW LTD.                       510(k) NO: K113576(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 18-MAY-12
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEFORTE SYSTEM BONE PLATE & SCREW
ARKIN CONSULTING GROUP            510(k) NO: K112457(SPECIAL)
ATTN: PAUL  SUMNER                PHONE NO : 770 448 7529   
1733 CANTON LANE                  SE DECISION MADE: 18-MAY-12
MARIETTA GA 30062 2679            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CONCENTRIC BALLOON GOOGLE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K112698(TRADITIONAL)
ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 18-MAY-12
MENTOR OH 44060                   510(k) STATEMENT
 
DEVICE: R&D INNOVATION PEDICLE SCREW SYSTEM
R&D INNOVATION, LLC               510(k) NO: K120091(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 561 702 6544   
4628 NORTHPARK DRIVE              SE DECISION MADE: 18-MAY-12
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES MATRIX SYSTEM
SYNTHES SPINE                     510(k) NO: K120928(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LN EAST              SE DECISION MADE: 18-MAY-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICROCAM CAPSULE ENDOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K111450(TRADITIONAL)
ATTN: JEFFREY  ROBERTS            PHONE NO : 508 643 0434   
40 PLAIN STREET                   SE DECISION MADE: 18-MAY-12
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
BIOMET MANUFACTURING, INC.        510(k) NO: K113271(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   
56 EAST BELL DR. P.O BOX 587      SE DECISION MADE: 18-MAY-12
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORION II CT CVC
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K113622(TRADITIONAL)
ATTN: NOLA  BENSTOG               PHONE NO : 801 773 7798   
803 North 1250 West Suite 1       SE DECISION MADE: 18-MAY-12
Centerville UT 84014              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI)
K2M, INC.                         510(k) NO: K120099(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 18-MAY-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PERMACOL SURGICAL IMPLANT
COVIDIEN LLC                      510(k) NO: K120605(TRADITIONAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
15 CROSBY DR                      SE DECISION MADE: 18-MAY-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XPERT FLU  GENEXPERT DX SYSTEMS (GX-I, GX-IV)
CEPHEID                           510(k) NO: K120911(TRADITIONAL)
ATTN: KERRY J FLOM                PHONE NO : 408 400 8460   
904 CARIBBEAN DRIVE               SE DECISION MADE: 18-MAY-12
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K121207(SPECIAL)
ATTN: CYNTHIA  HUNG               PHONE NO : 886 366868 68
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 18-MAY-12
HSINCHU CITY,    TW 30077         510(k) STATEMENT
 
DEVICE: LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
BIO-RAD LABORATORIES              510(k) NO: K121143(TRADITIONAL)
ATTN: SUZSNNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 18-MAY-12
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SRS ENDOSCOPIC STAPLING SYSTEM
MEDIGUS, LTD.                     510(k) NO: K120299(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 18-MAY-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENESIS II PS NON-MODULAR FEMORAL COMPONENT
SMITH & NEPHEW, INC.              510(k) NO: K120698(SPECIAL)
ATTN: XIANG  ZHANG                PHONE NO : 901 399 6929   
1450 BROOKS RD.                   SE DECISION MADE: 18-MAY-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
CLINIQA CORPORATION               510(k) NO: K121237(TRADITIONAL)
ATTN: DAWN  GAST                  PHONE NO : 760 571 5255   
288 Distribution Street           SE DECISION MADE: 18-MAY-12
San Marcos CA 92078               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FALLER TROCAR
MEDIGROUP, INC.                   510(k) NO: K120130(TRADITIONAL)
ATTN: IRENE  NAVIS                PHONE NO : 630 554 5533   
14 A STONEHILL RD.                SE DECISION MADE: 21-MAY-12
OSWEGO IL 60543                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DYNA LOCKING ANKLE NAIL
U&I CORP.                         510(k) NO: K120419(TRADITIONAL)
ATTN: GYEONG-JE  KWON             PHONE NO : 82 318 520102
529-1 YONGHYUN-DONG               SE DECISION MADE: 21-MAY-12
UIJUNGBU, KYUNGGI-DO    KR 480-050510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K120495(SPECIAL)
ATTN: YUMI  WACKERFUSS            PHONE NO : 763 255 0785   
ONE SCIMED PLACE                  SE DECISION MADE: 21-MAY-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VISIONSEARCH 1
VISIONSEARCH PTY LTD              510(k) NO: K120104(TRADITIONAL)
ATTN: ARTHUR  BRANDWOOD           PHONE NO : 612 990 62984
460 PACIFIC HIGHWAY SUITE 408     SE DECISION MADE: 21-MAY-12
ST LEONARDS    AS 2074            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
MERZ DENTAL GMBH                  510(k) NO: K120404(TRADITIONAL)
ATTN: RICHARD G HUNTER            PHONE NO : 505 400 4992   
5616 MARIOLA P1 NE                SE DECISION MADE: 21-MAY-12
ALBUQURQUE NM 87111               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHODONTIC FLOWABLE BRACKET ADHESIVE
NOVOCOL, INC.                     510(k) NO: K120619(ABBREVIATED)
ATTN: STEVE  RUDOLPH              PHONE NO : 303 665 7535   
416 SOUTH TAYLOR AVE.             SE DECISION MADE: 21-MAY-12
LOUISVILLE CO 80027               510(k) STATEMENT
 
DEVICE: SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
REX MEDICAL                       510(k) NO: K113103(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 22-MAY-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
NEXSTIM OY                        510(k) NO: K112881(TRADITIONAL)
ATTN: RAINER  HARJUNPAA           PHONE NO : 358 927 271710
ELIMAENKATU 9 B                   SE DECISION MADE: 22-MAY-12
HELSINKI    FI FI-00510           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
BAXTER HEALTHCARE CORPORATION - RE510(k) NO: K120443(TRADITIONAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 847 270 4871   
1620 WAUKEGAN ROAD BUILDING R     SE DECISION MADE: 22-MAY-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TEMPSPAN CLEAR MATRIX
PENTRON CLINICAL                  510(k) NO: K120013(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7400   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 22-MAY-12
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K120042(SPECIAL)
ATTN: MEIRU  LI                   PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 22-MAY-12
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNIVERSAL DIGITAL INTERFACE (UDI) 1717
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K112527(TRADITIONAL)
ATTN: ARIEL  MARCIANO             PHONE NO : 407 719 9853   
325 HARRIS DRIVE                  SE DECISION MADE: 22-MAY-12
AURORA OH 44202                   510(k) STATEMENT
 
DEVICE: VIEWRAY SYSTEM
VIEWRAY INCORPORATED              510(k) NO: K111862(TRADITIONAL)
ATTN: JANICE  BROWNLEE            PHONE NO : 440 703 3210   
2 THERMOFISHER WAY                SE DECISION MADE: 22-MAY-12
OAKWOOD OH 44146                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CELL SAVER ELITE
HAEMONETICS CORP.                 510(k) NO: K120586(TRADITIONAL)
ATTN: GREG  CALDER                PHONE NO : 781 356 9538   
400 Wood Rd                       SE DECISION MADE: 22-MAY-12
BRAINTREE MA 02184                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
BRIDGEPOINT MEDICAL               510(k) NO: K120533(TRADITIONAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
13355 10TH AVE N, SUITE #110      SE DECISION MADE: 22-MAY-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TAPER SET HIP SYSTEM RDP STEM
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K121263(SPECIAL)
ATTN:                             PHONE NO : 
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 22-MAY-12
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMPHIRION PLUS PTA CATHETER
MEDTRONIC INC.                    510(k) NO: K121265(SPECIAL)
ATTN: NAINESH  SUREJA             PHONE NO : 707 591 2912   
3576 UNOCAL PLACE                 SE DECISION MADE: 22-MAY-12
SANTA ROSA CA 95403 1774          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
OLSEN MEDICAL                     510(k) NO: K111262(TRADITIONAL)
ATTN: NUNIE  TABERMEJO            PHONE NO : 502 772 4286   
3230 COMMERCE CENTER PLACE        SE DECISION MADE: 23-MAY-12
LOUISVILLE KY 40211               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HIGH FIVE
CENTRAL MEDICARE SDN BHD          510(k) NO: K113440(TRADITIONAL)
ATTN: NICK  WANG                  PHONE NO : 909 860 1908   
1930 BREA CANYON ROAD DIAMOND BAR SE DECISION MADE: 23-MAY-12
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LUCENT OR LUCENT MAGNUM
SPINAL ELEMENTS, INC.             510(k) NO: K110632(TRADITIONAL)
ATTN: BENJAMIN A KIMBALL          PHONE NO : 760 607 0121   
2744 LOKER AVE. W. SUITE 100      SE DECISION MADE: 23-MAY-12
CARLSBAD CA 90210                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOMATOM PERSPECTIVE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113287(TRADITIONAL)
ATTN: KIM  MANGUM                 PHONE NO : 610 484 4912   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 23-MAY-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
ORTHOCON, INC.                    510(k) NO: K111575(TRADITIONAL)
ATTN: ROSEMARY  HARRY             PHONE NO : 914 357 2600   
1 Bridge St Ste 121               SE DECISION MADE: 23-MAY-12
Irvington NY 10533                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUNTOUCH TOPICAL HEMOSTATIC DRESSING
HUIZHOU FORYOU MEDICAL DEVICES CO,510(k) NO: K112800(TRADITIONAL)
ATTN: CHENGYU  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 23-MAY-12
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REACH SURGICAL STAPLERS
REACH SURGICAL, INC               510(k) NO: K120179(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 23-MAY-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PUSH-ON NEEDLE 30GX8MM
SCANDINAVIAN HEALTH LIMITED       510(k) NO: K120191(TRADITIONAL)
ATTN: SHARLIN  YEH                PHONE NO : 886 321 70303
NO. 136, KUO SHENG 2ND STREET     SE DECISION MADE: 23-MAY-12
TAOYUAN CITY    TW 33060          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
COLOPLAST A/S                     510(k) NO: K120284(TRADITIONAL)
ATTN: JANELL  COLLEY              PHONE NO : 612 287 4211   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 23-MAY-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MANUKA FILL
LINKS MEDICAL PRODUCTS, INC.      510(k) NO: K121227(TRADITIONAL)
ATTN: JAMES  SMITH                PHONE NO : 949 340 7261   
29442 POINTE ROYALE               SE DECISION MADE: 23-MAY-12
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
CARDINAL HEALTH, INC.             510(k) NO: K120934(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430  WAUKEGAN ROAD               SE DECISION MADE: 23-MAY-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TEMPUS CERVICAL PLATE SYSTEM
NEUROSTRUCTURES, LLC              510(k) NO: K120515(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DR                 SE DECISION MADE: 23-MAY-12
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MANUKA IG
LINKS MEDICAL PRODUCTS, INC.      510(k) NO: K120976(TRADITIONAL)
ATTN: JAMES  SMITH                PHONE NO : 949 340 7261   
29442 POINTE ROYALE               SE DECISION MADE: 23-MAY-12
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VANTAGE TITAN 3T
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120487(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DRIVE               SE DECISION MADE: 23-MAY-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PALOMAR VECTUS LASER
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K120622(TRADITIONAL)
ATTN: SHARON  TIMBERLAKE          PHONE NO : 781 993 2412   
15 NETWORK DR                     SE DECISION MADE: 23-MAY-12
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AERODR X70
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K121109(TRADITIONAL)
ATTN: SHIGEYUKI  KOJIMA           PHONE NO : 814 258 98429
NO. 1 SAKURA-MACHI, HINO-SHI      SE DECISION MADE: 23-MAY-12
TOKYO    JA 191-8511              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SOMATOM DEFINITION EDGE
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K120579(SPECIAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 23-MAY-12
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MYLABSOGNO
ESAOTE, S.P.A.                    510(k) NO: K121384(SPECIAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 23-MAY-12
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VILET VILET QUICK
RIVERPOINT MEDICAL                510(k) NO: K120556(ABBREVIATED)
ATTN: DOUG  ROWLEY                PHONE NO : 503 817 8001   
825 NE 25th Ave                   SE DECISION MADE: 23-MAY-12
Portland OR 97232                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEXUS CERVICAL FIXATION SYSTEM
L & K BIOMED CO., LTD             510(k) NO: K120879(SPECIAL)
ATTN: KI HYANG  KIM               PHONE NO : 822 262 41471
ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 23-MAY-12
SEOUL    KS 153803                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CONTOUR TECHNOLOGY MUSCLE STIMULATOR
CONTOUR TECHNOLOGY                510(k) NO: K111476(TRADITIONAL)
ATTN: SARA  PETRIE                PHONE NO : 612 396 9849   
8401 73RD AVENUE NORTH SUITE 63   SE DECISION MADE: 23-MAY-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
SEBIA                             510(k) NO: K112491(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 800 835 6497
PARC TECHNOLOGIQUE LEONARD DE VINCSE DECISION MADE: 24-MAY-12
EVRY    FR 91008                  510(k) STATEMENT
 
DEVICE: PRAEZIS PLUS
TATRAMED SPOL. S.R.O.             510(k) NO: K110644(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 W 5TH ST. 3RD FLOOR           SE DECISION MADE: 24-MAY-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
PRIMED HALBERSTADT MEDIZINTECHNIK 510(k) NO: K120079(TRADITIONAL)
ATTN: ALEXANDRA  SINGER           PHONE NO : 49 394 1668782
STRASSE DES 20. JULI NR.1         SE DECISION MADE: 24-MAY-12
HALBERSTADT    GM 38820           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K120425(TRADITIONAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 24-MAY-12
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
VENTLAB CORP.                     510(k) NO: K120118(TRADITIONAL)
ATTN: JAMES A COCHIE              PHONE NO : 336 753 5000   
155 BOYCE DRIVE                   SE DECISION MADE: 24-MAY-12
MOCKSVILLE NC 27028               510(k) STATEMENT
 
DEVICE: RHEA CUP
APEX MEDICAL TECHNOLOGIES, INC.   510(k) NO: K112165(TRADITIONAL)
ATTN: SCOTT  HERRICK              PHONE NO : 858 535 0012   
10064 MESA RIDGE CT., #202        SE DECISION MADE: 24-MAY-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
ADIN DENTAL IMPLANTS SYSTEM LTD   510(k) NO: K112585(SPECIAL)
ATTN: YANA  PRUS-GALYNSKY         PHONE NO : 972 464 26732
INDUSTRIAL ZONE ALON TAVOR, P.O. BSE DECISION MADE: 24-MAY-12
AFULA    IS 20187                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
BIOMET ORTHOPEDICS LLC.           510(k) NO: K112905(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   
P.O. BOX 587                      SE DECISION MADE: 24-MAY-12
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DUAL SPIKE TRANSFER DEVICE
B. BRAUN MEDICAL, INC.            510(k) NO: K120150(TRADITIONAL)
ATTN: BONNIE  KINCAID             PHONE NO : 610 596 2970   
901 MARCON BLVD.                  SE DECISION MADE: 24-MAY-12
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAYFIELD SKULL CLAMP
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K120633(TRADITIONAL)
ATTN: LINDSAY  MIGNONE            PHONE NO : 609 936 5583   
311 ENTERPRISE DR.                SE DECISION MADE: 24-MAY-12
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: K-ASSAY (R) FARRITIN REAGENT K-ASSAY (R) FERRITIN CALIBRATOR
KAMIYA BIOMEDICAL COMPANY         510(k) NO: K121232(TRADITIONAL)
ATTN: SHAWN  KAPLAN               PHONE NO : 206 575 8068   
12779 GATEWAY DR                  SE DECISION MADE: 24-MAY-12
SEATTLE WA 98168                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEKSELL GAMMA KNIFE PERFEXION
ELEKTA INSTRUMENT AB              510(k) NO: K120811(TRADITIONAL)
ATTN: VIVEKA  WRETMAN             PHONE NO : 011 468 58725400
KUNGSTENSGATAN 18                 SE DECISION MADE: 24-MAY-12
STOCKHOLM    SW S-103 93          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
GEISTLICH PHARMA AG               510(k) NO: K120601(TRADITIONAL)
ATTN: DANIEL A KRACOV             PHONE NO : 202 942 5120   
555 TWELFTH STREET, NW            SE DECISION MADE: 24-MAY-12
WASHINGTON DC 20004 1206          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REMOTE PRESENCE SYSTEM
INTOUCH HEALTH, INC.              510(k) NO: K120895(TRADITIONAL)
ATTN: STEVE  SIDWELL              PHONE NO : 805 562 8686   
6330 HOLLISTER AVE.               SE DECISION MADE: 24-MAY-12
GOLETA CA 93117                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L&K BIOMED CO., LTD               510(k) NO: K120840(TRADITIONAL)
ATTN: KI HYANG  KIM               PHONE NO : 822 262 41471
#1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 24-MAY-12
GEUMCHEON-GU, SEOUL    KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PAX-DUO3D PLUS, PCT-5000
VATECH CO., LTD.                  510(k) NO: K121236(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 24-MAY-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
AESCULAP, INC.                    510(k) NO: K120559(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 24-MAY-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ES BOND
SPIDENT CO., LTD.                 510(k) NO: K120767(TRADITIONAL)
ATTN: I.S.  WHANG                 PHONE NO : 823 281 94570
312, 151B-6L NAMDONGGONGDAN       SE DECISION MADE: 24-MAY-12
INCHEON    KS 405-821             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
OPTOACOUSTICS LTD                 510(k) NO: K121239(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 24-MAY-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MOBILE VERSA LIGHT
MEDTEK LIGHTING CORP              510(k) NO: K111049(TRADITIONAL)
ATTN: ROBERT  WAGNER              PHONE NO : 865 982 5552   
1131 ANTHEM VIEW LANE             SE DECISION MADE: 25-MAY-12
KNOXVILLE TN 37922                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
SEBIA                             510(k) NO: K112550(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 800 835 6497   
400-1705 CORPORATE DRIVE          SE DECISION MADE: 25-MAY-12
NORCROSS GA 30096                 510(k) STATEMENT
 
DEVICE: HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
HEALTH & LIFE CO., LTD.           510(k) NO: K110074(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 25-MAY-12
CHUNG HO CITY, TAIPEI    TW 235   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VPAP ADAPT
RESMED CORP                       510(k) NO: K113801(TRADITIONAL)
ATTN: DAVID D D'CRUZ              PHONE NO : 858 836 5984   
9001 Spectrum Center Boulevard    SE DECISION MADE: 25-MAY-12
KEARNY MESA CA 92123              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPTOS ADVANCE
OPTOS PLC                         510(k) NO: K113696(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202 367 5813   
555 13TH STREET, NW               SE DECISION MADE: 25-MAY-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHASER HRS2 HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K120080(TRADITIONAL)
ATTN: GLEN  EMELOCK               PHONE NO : 781 665 9893   
32 HARRISON ST.                   SE DECISION MADE: 25-MAY-12
MELROSE MA 02176                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES ACIS/VERTEBRAL SPACER CR
SYNTHES (USA) LLC                 510(k) NO: K120275(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 25-MAY-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: I-FUSE HAMMER TOE SYSTEMS
ORTHOPRO LLC                      510(k) NO: K113006(TRADITIONAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD.                SE DECISION MADE: 25-MAY-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VPAP TX
RESMED LTD.                       510(k) NO: K113714(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 25-MAY-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PATIENT MONITOR
ADVANCED INSTRUMENTS, INC.        510(k) NO: K120631(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 25-MAY-12
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHOYANG THERMAL MASSAGER
CHOYANG MEDICAL INSTRUMENT CO., LT510(k) NO: K111941(TRADITIONAL)
ATTN: SHIN  KUK YOO               PHONE NO : 714 313 7442   
8 EAST BROADWAY SUITE 611         SE DECISION MADE: 25-MAY-12
SALT LAKE CITY UT 84111           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: K-LASER
ELTECH S.R.L                      510(k) NO: K120604(TRADITIONAL)
ATTN: RICHARD  ALBRIGHT           PHONE NO : 615 595 7749   
1185 W. MAIN ST                   SE DECISION MADE: 25-MAY-12
FRANKLIN TN 37064                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
MEDTRONIC INC.                    510(k) NO: K120612(SPECIAL)
ATTN: KELLEY  BREHEIM             PHONE NO : 763 514 9831   
7611 NORTHLAND DRIVE              SE DECISION MADE: 25-MAY-12
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPIRTIUS CUFF INFLATION SYRINGE
SPIRITUS TECHNOLOGIES LLC         510(k) NO: K112915(TRADITIONAL)
ATTN: BRANDON W CLOSE             PHONE NO : 913 205 5493   
12005 W. 100TH TERRACE            SE DECISION MADE: 25-MAY-12
LENEXA KS 66215                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
COPAN FLOCK TECHNOLOGIES          510(k) NO: K121039(TRADITIONAL)
ATTN: CYNTHIA  SINCLAIR           PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 25-MAY-12
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMT T-FASTENER ANCHOR KIT
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K120587(TRADITIONAL)
ATTN: ELIZABETH  MEYER            PHONE NO : 440 717 4000   
8000 KATHERINE BOULEVARD          SE DECISION MADE: 25-MAY-12
BRECKSVILLE OH 44141              510(k) STATEMENT
 
DEVICE: RANGE SPINAL SYSTEM, UNIT ROD
K2M, INC.                         510(k) NO: K120899(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 25-MAY-12
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
TELEFLEX MEDICAL, INC.            510(k) NO: K121380(SPECIAL)
ATTN: NATALIE  SMITH              PHONE NO : 919 433 8049   
2917 WECK DR.                     SE DECISION MADE: 25-MAY-12
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
GAMBRO RENAL PRODUCTS             510(k) NO: K120333(TRADITIONAL)
ATTN: FEI  LAW                    PHONE NO : 386 481 1143   
1845 MASON AVE.                   SE DECISION MADE: 25-MAY-12
DAYTONA BEACH FL 32117 5102       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UPSTREAM GR CATHETER
UPSTREAM PERIPHERAL TECHNOLOGIES  510(k) NO: K120964(TRADITIONAL)
ATTN: JANICE  HOGAN               PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 25-MAY-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
HANSON MEDICAL, INC.              510(k) NO: K111004(TRADITIONAL)
ATTN: KATE  WHITIN                PHONE NO : 650 404 5841   
800 EAST MIDDLEFIELD RD           SE DECISION MADE: 29-MAY-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
ORTHO SOLUTIONS LIMITED           510(k) NO: K120360(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 29-MAY-12
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K113561(TRADITIONAL)
ATTN: JUDITH  ROSEN               PHONE NO : 973 576 0032   
10 POMEROY RD.                    SE DECISION MADE: 29-MAY-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SI-FIX SACROILIAC JOINT FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K110472(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 29-MAY-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNIMED TEMPERATURE PROBE
UNIMED MEDICAL SUPPLIES INC.      510(k) NO: K121427(TRADITIONAL)
ATTN: XINMEI  TAN                 PHONE NO : 86 755 26695165
NO.37, YANSHAN ROAD, SHEKOU       SE DECISION MADE: 29-MAY-12
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K111956(TRADITIONAL)
ATTN: HEATHER  VIELE              PHONE NO : 208 377 4800   
170 S SENECA SPRINGS WAY SUITE 105SE DECISION MADE: 30-MAY-12
STAR ID 83669                     510(k) STATEMENT
 
DEVICE: NERIA MULTI SUBCUTANEOUS INFUSION SET
UNOMEDICAL DEVICES S.A DE C.V     510(k) NO: K120395(TRADITIONAL)
ATTN: JOHN M LINDSKOG             PHONE NO : 45 48 167000
Avenida Fomento Industrial Lote 9 SE DECISION MADE: 30-MAY-12
Reynosa    MX C.P. 88736          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOSCOPIC RETRIEVAL DEVICE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K120084(TRADITIONAL)
ATTN: ERIC  MAYNARD               PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 30-MAY-12
MENTOR OH 44060                   510(k) STATEMENT
 
DEVICE: WIS1000
FORESEESON CUSTOM DISPLAYS, INC.  510(k) NO: K112621(ABBREVIATED)
ATTN: DANIEL  TOMLINSON           PHONE NO : 714 300 0540   
2210 E Winston Rd                 SE DECISION MADE: 30-MAY-12
Anaheim CA 92806                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOLOHEALTH STATION
SOLOHEALTH, INC.                  510(k) NO: K113402(TRADITIONAL)
ATTN: STEPHEN  KENDIG             PHONE NO : 770 622 4158   
11555 MEDLOCK BRIDGE, SUITE 190   SE DECISION MADE: 30-MAY-12
DULUTH GA 30097                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
MATERIALISE DENTAL NV             510(k) NO: K113739(TRADITIONAL)
ATTN: GEERT  APPELTANS            PHONE NO : 321 639 6620
TECHNOLOGIELAAN 15                SE DECISION MADE: 30-MAY-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROCARE PLUS VITRECTOMY SYSTEM
VISIONCARE DEVICES, INC.          510(k) NO: K120170(TRADITIONAL)
ATTN: KURTIS  MONTEGNA            PHONE NO : 530 243 5047   
1246 REDWOOD BLVD.                SE DECISION MADE: 30-MAY-12
REDDING CA 96003                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARTISAN SPACE MAINTENANCE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K120271(TRADITIONAL)
ATTN: LIN  WU                     PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 30-MAY-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3M SPOTON TEMPERATURE MONITORING SYSTEM
ARIZANT HEALTHCARE INC.           510(k) NO: K120412(TRADITIONAL)
ATTN: DAVID  WESTLIN              PHONE NO : 952 947 1277   
10393 WEST 70TH ST.               SE DECISION MADE: 30-MAY-12
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ERAPID NEBULIZER SYSTEM
PARI RESPIRATORY EQUIPMENT, INC.  510(k) NO: K112859(TRADITIONAL)
ATTN: JAMES L MCINTIRE            PHONE NO : 804 253 7274   
2943 OAKLAKE BLVD.                SE DECISION MADE: 30-MAY-12
MIDLOTHIAN VA 23112               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
BARD ACCESS SYSTEMS, INC.         510(k) NO: K120882(TRADITIONAL)
ATTN: HENRY  BOLAND               PHONE NO : 801 522 5000   
605 NORTH 5600 WEST               SE DECISION MADE: 30-MAY-12
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TANDEMHEART FEMORAL ARTERIAL CANNULA SET
CARDIACASSIST INC.                510(k) NO: K120543(TRADITIONAL)
ATTN: KATIE  DILLON               PHONE NO : 412 963 7770   
240 ALPHA DRIVE                   SE DECISION MADE: 30-MAY-12
PITTSBURGH PA 15238               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD EMERALD SAF-T SINGLE USE, HYPODERMIC
BECTON, DICKINSON AND COMPANY     510(k) NO: K121283(SPECIAL)
ATTN: KIMBERLY  LANE              PHONE NO : 201 847 7445   
1 BECTON DRIVE MC237              SE DECISION MADE: 30-MAY-12
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STAINLESS STEEL SPINAL SYSTEM
THEKEN SPINE, LLC                 510(k) NO: K120829(SPECIAL)
ATTN: DALE  DAVISON               PHONE NO : 330 239 7709   
1153 Medina Rd.                   SE DECISION MADE: 30-MAY-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOMNODENT G2
SOMNOMED INC.                     510(k) NO: K121340(TRADITIONAL)
ATTN: KATHRYN  JAYNE              PHONE NO : 888 447 6673   
7460 Warren Pkwy Ste 190          SE DECISION MADE: 30-MAY-12
Frisco TX 75034                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: HAMILTON-C1
HAMILTON MEDICAL AG               510(k) NO: K120574(ABBREVIATED)
ATTN: RALPH  AGUILA               PHONE NO : 418 166 06845
VIA CRUSCH 8                      SE DECISION MADE: 30-MAY-12
BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CELVER
CELLULOSE CONCEPTS LLC            510(k) NO: K111382(TRADITIONAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 843 1675   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 31-MAY-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GETINGE 700HC-E SERIES STEAM STERILIZER
GETINGE SOURCING LLC              510(k) NO: K120441(TRADITIONAL)
ATTN: BARB  SMITH                 PHONE NO : 585 214 6049   
1777 EAST HENRIETTA RD.           SE DECISION MADE: 31-MAY-12
ROCHESTER NY 14623 3133           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
COVIDIEN                          510(k) NO: K120944(TRADITIONAL)
ATTN: JENNIFER  SULLIVAN          PHONE NO : 508 452 1659   
15 HAMPSHIRE STREET               SE DECISION MADE: 31-MAY-12
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPECTRUM V.0
INTRINSIC MEDICAL IMAGING         510(k) NO: K121023(TRADITIONAL)
ATTN: STEPHEN J GOLDNER, JD, RAC  PHONE NO : 248 747 8008   
2550 SOUTH TELEGRAPH RD STE 108   SE DECISION MADE: 31-MAY-12
BLOOMFIELD HILLS MI 48304         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEAN AND BOOST
APEX DENTAL MATERIALS, INC.       510(k) NO: K120620(TRADITIONAL)
ATTN: CHRIS  KULTON               PHONE NO : 847 719 1133   
330 TELSER ROAD                   SE DECISION MADE: 31-MAY-12
LAKE ZURICH IL 60047              510(k) STATEMENT
 
DEVICE: ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
KCI USA, INC.                     510(k) NO: K120033(TRADITIONAL)
ATTN: SHANNON  SCOTT              PHONE NO : 210 515 4368   
6203 FARINON DR.                  SE DECISION MADE: 31-MAY-12
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ
EXACTECH, INC.                    510(k) NO: K121307(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 31-MAY-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLOSER TO NATURE
MAYBORN GROUP LIMITED             510(k) NO: K121322(TRADITIONAL)
ATTN: NEIL  HEWITT                PHONE NO : 441 912 501864
DUDLEY LANE CRAMLINGTON           SE DECISION MADE: 31-MAY-12
NORTHUMBERLAN    UK NE23 TRH      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: GUIDEMIA
GUIDEMIA TECHNOLOGIES, LLC        510(k) NO: K121466(TRADITIONAL)
ATTN: FEI  GAO                    PHONE NO : 714 391 2739   
4841 ASHBURY AVE.                 SE DECISION MADE: 31-MAY-12
CYPRESS CA 90630                  510(k) STATEMENT
                                  THIRD PARTY REVIEW
 
DEVICE: NCI SPATULA
FISCHER SURGICAL INC.             510(k) NO: K110734(TRADITIONAL)
ATTN: JESSICA  DIXON              PHONE NO : 314 303 7753   
1012 PALMER LANE, SUITE 200       SE DECISION MADE: 31-MAY-12
IMPERIAL MO 63052                 510(k) STATEMENT
 
 
                                                 TOTAL 510(k)s THIS PERIOD   307                                     
                                                 TOTAL WITH SUMMARIES        278                                     
                                                 TOTAL WITH STATEMENTS        29