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U.S. Department of Health and Human Services

Medical Devices

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April 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2012
 
 
DEVICE: HYBRID GRAFT
COOK BIOTECH, INC.                510(k) NO: K111695(TRADITIONAL)
ATTN: MARY A FADERAN, PHD, RAC    PHONE NO : 765 497 3355   
1425 INNOVATION PLACE             SE DECISION MADE: 02-APR-12
WEST LAFAYETTE IN 47906 1000      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
SMALL BONE INNOVATIONS INC.       510(k) NO: K112982(TRADITIONAL)
ATTN: JOHN  MINIER                PHONE NO : 215 428 1791   
1380 SOUTH PENNSYLVANIA AVENUE    SE DECISION MADE: 02-APR-12
MORRISVILLE PA 19067              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
MATERIALISE N.V.                  510(k) NO: K113829(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 321 639 6280
TECHNOLOGIELAAN 15                SE DECISION MADE: 02-APR-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: A BAER WITH ABAER I/O FUNCTION
NATUS MEDICAL INCORPORATED        510(k) NO: K112247(TRADITIONAL)
ATTN: CHARLES L MORIN             PHONE NO : 415 957 0101   
388 MARKET STREET SUITE 1460      SE DECISION MADE: 02-APR-12
SAN FRANCISCO CA 94111            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K120190(ABBREVIATED)
ATTN: ELIZABETH  DENG             PHONE NO : 909 465 9188   
5748 EAGLEWOOD PLACE              SE DECISION MADE: 02-APR-12
RANCHO CUCAMONGA CA 91739         510(k) STATEMENT
 
DEVICE: XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
XIAN FRIENDSHIP MEDICAL ELECTRONIC510(k) NO: K112426(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
JIANXIANG YUAN #209 BEI SI HU ZHONSE DECISION MADE: 02-APR-12
HAIDIAN DIS., BEIJING    CH 100083510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEAR + BRILLIANT LASER SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K120433(SPECIAL)
ATTN: KRISTINE  FOSS              PHONE NO : 510 780 4657   
25881 Industrial Blvd             SE DECISION MADE: 02-APR-12
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K120802(SPECIAL)
ATTN: SARAH  HOLTGREWE            PHONE NO : 901 867 4476   
5677 AIRLINE RD.                  SE DECISION MADE: 02-APR-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TIGER SPINE SYSTEM
CORELINK LLC                      510(k) NO: K120696(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 02-APR-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PATHASSIT LIGHT SEEKER
ENTELLUS MEDICAL, INC.            510(k) NO: K120735(SPECIAL)
ATTN: GARRETT P AHLBORG           PHONE NO : 763 463 7074   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 02-APR-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
PENUMBRA, INC.                    510(k) NO: K120330(TRADITIONAL)
ATTN: EMILLY T NURTHEN            PHONE NO : 510 748 3314   
1351 Harbor Bay Parkway           SE DECISION MADE: 02-APR-12
Alameda CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PAGEWRITER TC 20, 30, 50, 70
PHILIPS MEDICAL SYSTEMS           510(k) NO: K113144(TRADITIONAL)
ATTN: PAUL  SCHRADER              PHONE NO : 978 659 2404   
3000 MINUTEMAN RD.                SE DECISION MADE: 03-APR-12
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: EPICARE YAG
LIGHT AGE, INC.                   510(k) NO: K113115(TRADITIONAL)
ATTN: ELIZABETH  REDDINGTON       PHONE NO : 732 563 0600   
500 APGAR DRIVE                   SE DECISION MADE: 03-APR-12
SOMERSET NJ 08873 1150            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
PLAXTRON INDUSTRIAL (M) SDN. BHD. 510(k) NO: K120065(TRADITIONAL)
ATTN: MING-YIE  JAN               PHONE NO : 886 731 19989
NO. 15-2, LANE 26, MINCYUAN 1ST RDSE DECISION MADE: 03-APR-12
KAOHSIUNG CITY    TW 802          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
GUNNELL, INC.                     510(k) NO: K111636(TRADITIONAL)
ATTN: ANDREW  EVANCHO             PHONE NO : 800 551 0055   
8440 STATE P.O. BOX 308           SE DECISION MADE: 03-APR-12
MILLINGTON MI 48746               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RTVUE XR OCT
OPTOVUE, INC.                     510(k) NO: K120238(SPECIAL)
ATTN: JOHN J TALARICO             PHONE NO : 510 623 8868   
45531 Northport Loop W            SE DECISION MADE: 03-APR-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AVAIRA (ENFILCON A) CONTACT LENS
COOPERVISION, INC.                510(k) NO: K113759(SPECIAL)
ATTN: KARIN  GASTINEAU            PHONE NO : 925 321 3732   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 03-APR-12
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STAPHYLOCOCCUS QUICKFISH BC
ADVANDX, INC.                     510(k) NO: K113371(TRADITIONAL)
ATTN: BENJAMIN S CRYSTAL          PHONE NO : 781 376 0009   
400 TRADECENTER SUITE 6990        SE DECISION MADE: 03-APR-12
WOBURN MA 01801                   510(k) STATEMENT
 
DEVICE: SECURIS SPINAL FIXATION
CUMTOM SPINE                      510(k) NO: K113361(TRADITIONAL)
ATTN: DAVID  BRUMFIELD            PHONE NO : 973 265 5043   
1140 PARSIPPANY BLVD. SUITE 201   SE DECISION MADE: 03-APR-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REPROCESSED FEMORAL COMPRESSION DEVICE
STERILMED, INC.                   510(k) NO: K120204(TRADITIONAL)
ATTN: JASON  SKRAMSTED            PHONE NO : 763 488 3483   
11140 73RD AVE. NORTH             SE DECISION MADE: 03-APR-12
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDLINE STOPCOCK AND MANIFOLD
MEDLINE INDUSTRIES, INC.          510(k) NO: K120069(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 03-APR-12
MUNDELEIN IL 60060                510(k) STATEMENT
 
DEVICE: HAMILTON-T1
HAMILTON MEDICAL AG               510(k) NO: K120670(SPECIAL)
ATTN: RALPH  AGUILA               PHONE NO : 418 166 06845
VIA CRUSCH 8                      SE DECISION MADE: 03-APR-12
BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENCORE 26 ADVANTAGE KIT
BOSTON SCIENTIFIC CORP.           510(k) NO: K120694(SPECIAL)
ATTN: ADRIENNE  HOTCHKISS         PHONE NO : 763 255 0334   
ONE SCIMED PLACE                  SE DECISION MADE: 03-APR-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
JETPREP, LTD.                     510(k) NO: K111274(TRADITIONAL)
ATTN: JOHN  SMITH                 PHONE NO : 202 637 3638   
COLUMBIA SQUARE 555 13TH STREET, NSE DECISION MADE: 04-APR-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
TECHNOLOGY DELIVERY SYSTEMS, INC. 510(k) NO: K111480(TRADITIONAL)
ATTN: JAMES HARVEY  KNAUSS        PHONE NO : 832 675 9281   
1516 THALIA STREET                SE DECISION MADE: 04-APR-12
NEW ORLEANS LA 70130              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
FOCUS DIAGNOSTICS, INC.           510(k) NO: K113433(TRADITIONAL)
ATTN: SHARON  YOUNG               PHONE NO : 562 240 6680   
11331 Valley View Street          SE DECISION MADE: 04-APR-12
CYPRESS CA 90630                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
CODMAN & SHURTLEFF, INC.          510(k) NO: K120686(SPECIAL)
ATTN: KIM  FONDA                  PHONE NO : 409 433 1420   
325 PARAMOUNT DR.                 SE DECISION MADE: 04-APR-12
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVEREST SPINAL SYSTEM
K2M, INC.                         510(k) NO: K120656(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DRIVE SE               SE DECISION MADE: 04-APR-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
COVIDIEN                          510(k) NO: K120674(SPECIAL)
ATTN: WING  NG                    PHONE NO : 508 261 6596   
15 HAMPSHIRE STREET               SE DECISION MADE: 04-APR-12
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
SMITH & NEPHEW, INC.              510(k) NO: K120667(SPECIAL)
ATTN: DAVID  HENLEY               PHONE NO : 901 399 6487   
1450 BROOKS RD.                   SE DECISION MADE: 04-APR-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
ASI MEDICAL, INC.                 510(k) NO: K110481(TRADITIONAL)
ATTN: JOHN  MCPEEK                PHONE NO : 303 766 3646   
14550 E EASTER AVE. SUITE 700     SE DECISION MADE: 05-APR-12
CENTENNIAL CO 80112               510(k) STATEMENT
 
DEVICE: SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
HANDPIECE HEADQUARTERS INC. - HPR 510(k) NO: K113674(TRADITIONAL)
ATTN: TINA  STEFFANIE-OAK         PHONE NO : 717 335 7230   
620 S. PLACENTIA AVE              SE DECISION MADE: 05-APR-12
PLACENTIA CA 92870                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K113626(TRADITIONAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 05-APR-12
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUCAL
PULPDENT CORPORATION              510(k) NO: K120003(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617 926 6666   
80 Oakland St                     SE DECISION MADE: 05-APR-12
WATERTOWN MA 02472                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STELLAR 150
RESMED GERMANY INC.               510(k) NO: K113640(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUMA CENTER BOULEVARD   SE DECISION MADE: 05-APR-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GRINDCARE MEASURE
MEDOTECH A/S                      510(k) NO: K113677(TRADITIONAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
13417 QUIVAS ST                   SE DECISION MADE: 05-APR-12
WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 2GC HIP/KNEE MODULAR SPACER
MANDELL HORWITZ CONSULTANTS LLC   510(k) NO: K112470(TRADITIONAL)
ATTN: DIANE M HORWITZ             PHONE NO : 703 307 2921   
2995 STEVEN MARTIN DR             SE DECISION MADE: 05-APR-12
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STEAM DOT BLU PROCESS INDICATOR
PROPPER MFG. CO., INC.            510(k) NO: K111453(ABBREVIATED)
ATTN: ANDREW  SHARAVARA           PHONE NO : 718 392 6650   
36-04 SKILLMAN AVE.               SE DECISION MADE: 05-APR-12
LONG ISLAND CITY NY 11101         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVANTAGE LASER SYSTEM
LUTRONIC CORPORATION              510(k) NO: K113502(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 05-APR-12
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CMI IMPLANT IS SYSTEM
NEOBIOTECH CO., LTD.              510(k) NO: K113554(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 05-APR-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EAGLE EYE PLATINUM ST CATHETER
VOLCANO CORPORATION               510(k) NO: K120697(SPECIAL)
ATTN: MARILYN  POURAZAR           PHONE NO : 858 720 4116   
3661 Valley Centre Drive Suite 200SE DECISION MADE: 05-APR-12
San Diego CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
CHOICE SPINE, LP                  510(k) NO: K120570(TRADITIONAL)
ATTN: MARK  BEKKALA               PHONE NO : 865 246 3333   
400 Erin Dr                       SE DECISION MADE: 05-APR-12
KNOXVILLE TN 37919                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
COLOPLAST A/S                     510(k) NO: K120828(SPECIAL)
ATTN: REBEKA  STOLTMAN            PHONE NO : 612 302 4997   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 05-APR-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CERVICAL PLATE
EISERTECH, LLC                    510(k) NO: K113170(TRADITIONAL)
ATTN: LUKAS  EISERMANN            PHONE NO : 888 262 2817   
2555 FRONT STREET                 SE DECISION MADE: 06-APR-12
SAN DIEGO CA 92103                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
HOLOGIC, INC.                     510(k) NO: K120388(SPECIAL)
ATTN: EILEEN M BOYLE              PHONE NO : 781 999 7781   
35 CROSBY DR.                     SE DECISION MADE: 06-APR-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
APEX BIOTECHNOLOGY CORP.          510(k) NO: K120448(SPECIAL)
ATTN: LISA  LIU                   PHONE NO : 011 886 35641952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 06-APR-12
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWER WHEELCHAIR
SUZHOU KD MEDICAL APPLIANCE CO., L510(k) NO: K113463(TRADITIONAL)
ATTN: JUNNATA  CHANG              PHONE NO : 886 422 465396
16F-2(16A), NO. 462 SEC. 2 CHONGDESE DECISION MADE: 06-APR-12
TAICHUNG    TW 406                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAYSTATION
RAYSEARCH LABORATORIES AB         510(k) NO: K120387(TRADITIONAL)
ATTN: DAVID  HEDFORS              PHONE NO : 46 722 366110
SVEAVAGEN 25                      SE DECISION MADE: 06-APR-12
STOCKHOLM    SW 111 34            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NANOFUSE DBM
NANOTHERAPEUTICS                  510(k) NO: K120279(TRADITIONAL)
ATTN: GREGG  RITTER               PHONE NO : 386 462 9663   
13859 PROGRESS BLVD SUITE 300     SE DECISION MADE: 06-APR-12
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNAPSE 3D BASE TOOLS
FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K120361(TRADITIONAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVENUE                   SE DECISION MADE: 06-APR-12
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARTHREX BIO-SUTURE
ARTHREX, INC.                     510(k) NO: K112899(TRADITIONAL)
ATTN: SALLY  FOUST                PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 06-APR-12
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTI-MODALITY IMAGE FUSION
IGT LLC DBA EIGEN                 510(k) NO: K120187(TRADITIONAL)
ATTN: WILLIAM  MANDEL             PHONE NO : 530 274 1240   
13366 GRASS VALLEY AVENUE         SE DECISION MADE: 06-APR-12
GRASS VALLEY CA 95945             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ETHEREA
REGULATORY INSIGHT, INC.          510(k) NO: K112505(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S.COTTONWOOD COURT           SE DECISION MADE: 06-APR-12
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT
 
DEVICE: SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K120095(TRADITIONAL)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880 8097   
325 PARAMOUNT DR.                 SE DECISION MADE: 06-APR-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUILION PRIME
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120710(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 06-APR-12
TUSTIN CA 92781                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EOS
EOS IMAGING                       510(k) NO: K120721(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 06-APR-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OEC 9900 ELITE
GE HEALTHCARE SURGERY GE OEC MEDIC510(k) NO: K120613(SPECIAL)
ATTN: GERALD  BUSS                PHONE NO : 801 517 6591   
384 WRIGHT BROTHERS DRIVE         SE DECISION MADE: 06-APR-12
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMAGE1 GI CCU MODEL 22203020-114
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K111997(TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 424 218 8379   
2151 E. GRAND AVE.                SE DECISION MADE: 06-APR-12
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THE DOME GX4MP COLOR NONITOR
NDS SURGICAL IMAGING              510(k) NO: K120709(SPECIAL)
ATTN: JIM  LENG                   PHONE NO : 408 776 0085   
5750 HELLYER AVENUE               SE DECISION MADE: 06-APR-12
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AEROSYNC FOR AERODR SYSTEM
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K120477(TRADITIONAL)
ATTN: RESSELL  MUNVES             PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 09-APR-12
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PIXEL APP
GAUSS SURGICAL, INC.              510(k) NO: K120473(TRADITIONAL)
ATTN: PEGGY  MCLAUGHLIN           PHONE NO : 650 520 7284   
22700 ALCALDE RD                  SE DECISION MADE: 09-APR-12
SUNNYVALE CA 95014                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPSTONE CONTROL SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K120368(TRADITIONAL)
ATTN: JULIE  BASSETT              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 09-APR-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SONIXGPS VASCULAR ACCESS NEEDLE KIT
ULTRASONIX MEDICAL CORPATION      510(k) NO: K120349(TRADITIONAL)
ATTN: CHAS  YU                    PHONE NO : 604 279 8550
130-4311 VIKING WAY               SE DECISION MADE: 09-APR-12
RICHOND, BC    CA V6V 2K9         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: WEIGHT AND BODY FAT SCALE SHINE BS0105
SHINE OVERSEAS MARKETING LIMITED  510(k) NO: K112149(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 09-APR-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
ASCENSION ORTHOPEDIC              510(k) NO: K112481(TRADITIONAL)
ATTN: BRADLEY W STRASSER          PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 09-APR-12
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
ACON LABORATORIES, INC.           510(k) NO: K112653(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 MESA RIM RD.                SE DECISION MADE: 09-APR-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STERILE LUBRICATING JELLY
JIANERKANG MEDICAL DRESSING COMPAN510(k) NO: K112110(TRADITIONAL)
ATTN: JORDON  CHU                 PHONE NO : 008 651 982444628
ZHIXI TOWN                        SE DECISION MADE: 10-APR-12
JINTAN CITY, JIANGSU    CH 213251 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
SOLANA SURGICAL LLC               510(k) NO: K120390(TRADITIONAL)
ATTN: LOUISE  ROCHT               PHONE NO : 901 818 1860   
6363 POPLAR AVE SUITE 434         SE DECISION MADE: 10-APR-12
MEMPHIS TN 38119                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MINI MAXLOCK EXTREME PLATING SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K120157(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 10-APR-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEFLEX
NUXEN S.R.L.                      510(k) NO: K113608(TRADITIONAL)
ATTN: HERNAN  ILARI               PHONE NO : 541 146 446966
9741 JUAN B JUSTO                 SE DECISION MADE: 10-APR-12
BUENOS AIRES    AR C1408ALB       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUILION ONE
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K113466(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 10-APR-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUILION CXL
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K112989(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR.                 SE DECISION MADE: 10-APR-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PEDCAT
CURVEBEAM, LLC                    510(k) NO: K113548(TRADITIONAL)
ATTN: DAVID W COWAN               PHONE NO : 267 483 8081   
175 TITUS AVE SUITE 300           SE DECISION MADE: 10-APR-12
WARRINGTON PA 18976               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
WELCH ALLYN, INC.                 510(k) NO: K120774(SPECIAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. PO BOX 220     SE DECISION MADE: 10-APR-12
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FINESSE PERSONAL INSULIN DELIVERY PATCH
CALIBRA MEDICAL, INC.             510(k) NO: K111924(TRADITIONAL)
ATTN: RICHARD J MEADER            PHONE NO : 650 298 4740   
220 SAGINAW DRIVE                 SE DECISION MADE: 10-APR-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORATECT ORAL FLUID DRUG SCREEN DEVICES
BRANAN MEDICAL CORPORATION        510(k) NO: K103227(TRADITIONAL)
ATTN: HUIYING  WANG               PHONE NO : 949 598 7166   
140 TECHNOLOGY DRIVE SUITE 400    SE DECISION MADE: 11-APR-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
RX DEVICES LLC                    510(k) NO: K112073(TRADITIONAL)
ATTN: CHARLES  HOKANSON           PHONE NO : 610 715 3263   
19200 ASHVILLE HWY                SE DECISION MADE: 11-APR-12
LANDRUM SC 29356 9021             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BORRELIA BURGDORFERI IGG BLOT TEST
GOLD STANDARD DIAGNOSTICS         510(k) NO: K113847(TRADITIONAL)
ATTN: NAPOLEON  MONCE             PHONE NO : 530 759 8000   
2851 SPAFFORD                     SE DECISION MADE: 11-APR-12
Davis CA 95618                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KONAN SPECULAR MICROSCOPE XIV
KONAN MEDICAL, INC.               510(k) NO: K120264(SPECIAL)
ATTN: DAVID S FERNQUIST           PHONE NO : 949 466 7137   
2976 CALLE GAUCHO                 SE DECISION MADE: 11-APR-12
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TITAN MODULAR TOTAL SHOULDER SYSTEM
ASCENSION ORTHOPEDIC              510(k) NO: K112438(SPECIAL)
ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 11-APR-12
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEURO CHECK DEVICE WITH IO-FLEX WIRE
BAXANO, INC.                      510(k) NO: K113533(SPECIAL)
ATTN: EDWARD  SINCLAIR            PHONE NO : 408 514 2200   
655 River Oaks Pkwy               SE DECISION MADE: 11-APR-12
San Jose CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
RAUMEDIC AG                       510(k) NO: K120252(TRADITIONAL)
ATTN: REINER  THIEM               PHONE NO : 499 252 3590
HERRMANN-STAUDINGER-STR. 2        SE DECISION MADE: 11-APR-12
HELMBRECHTS    GM D 95233         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
STARBOARD MEDICAL, LLC            510(k) NO: K111050(TRADITIONAL)
ATTN: ANTHONY  BERAN              PHONE NO : 714 283 3099   
22845 SAVI RANCH PKWY SUITE H     SE DECISION MADE: 12-APR-12
Yorba Linda CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
PARKELL, INC.                     510(k) NO: K113839(TRADITIONAL)
ATTN: DANIEL R SCHECHTER          PHONE NO : 631 249 1134   
300 EXECUTIVE DR.                 SE DECISION MADE: 12-APR-12
EDGEWOOD NY 11717                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K113768(SPECIAL)
ATTN: MEIRU  LI                   PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 12-APR-12
NEW TAIPEI CITY    TW 248         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BILI-THERAPY PAD TYPE
ATOM MEDICAL CORPORATION          510(k) NO: K111547(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 12-APR-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STERILE INSULIN PEN NEEDLE
SHINA CORP.                       510(k) NO: K113186(TRADITIONAL)
ATTN: JISEOP  JEONG               PHONE NO : 82 41 8538571
691-1, BOHEUNG-RI USEONG-MYEON, GOSE DECISION MADE: 12-APR-12
CHUNGCHENGNAM-DO    KS 314864     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NATURALASE CO2 LASER SYSTEM
FOCUS MEDICAL, LLC.               510(k) NO: K110333(TRADITIONAL)
ATTN: JOHN  LEE                   PHONE NO : 203 730 8885   
23 FRANCIS J. CLARKE CIRCLE       SE DECISION MADE: 12-APR-12
BETHEL CT 06801                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
AMERICAN I.V. PRODUCTS, INC.      510(k) NO: K120209(TRADITIONAL)
ATTN: MAJDI  SHOMALI              PHONE NO : 800 990 2911   
7485 SHIPLEY AVE.                 SE DECISION MADE: 12-APR-12
HARMANS MD 21077                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
GALT MEDICAL                      510(k) NO: K112398(SPECIAL)
ATTN: BETSY  CORTELLONI           PHONE NO : 770 831 4294   
5203 BRISTOL INDUSTRIAL WAY       SE DECISION MADE: 12-APR-12
BUFORD GA 30518                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CURAD ANTIBACTERIAL BANDAGE
MEDLINE INDUSTRIES, INC.          510(k) NO: K113583(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 12-APR-12
MUNDELEIN IL 60060                510(k) STATEMENT
 
DEVICE: HEMCON HEMOSTATIC GEL
HEMCON MEDICAL TECHNOLOGIES EUROPE510(k) NO: K112215(TRADITIONAL)
ATTN: KENDRA  RATHKEY             PHONE NO : 503 245 0459   
10575 SW CASCADE AVENUE, SUITE 130SE DECISION MADE: 12-APR-12
PORTLAND OR    97223-4363         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASCEND SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K120794(SPECIAL)
ATTN: BRAHIM  HADRI               PHONE NO : 781 249 8030   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 13-APR-12
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMARTEPIL,DEPILASE YAG LASE PLUS
CASTLE LASER SYSTEMS, LIMITED     510(k) NO: K112141(TRADITIONAL)
ATTN: RAYMOND R BLANCHE           PHONE NO : 973 539 7444   
641 SSHUNPIKE RD SUITE 311        SE DECISION MADE: 13-APR-12
CHATHAM NJ 07928                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARVISION DR 7000F
JPI HEALTHCARE CO., LTD           510(k) NO: K102327(TRADITIONAL)
ATTN: WILLIAM  LITTLE             PHONE NO : 516 513 1330   
170-5 Guro-3 Dong, #608 KURO-GU   SE DECISION MADE: 13-APR-12
Seoul    KS 152-847               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTRABEAM NEEDLE APPLICATOR
CARL ZEISS SURGICAL GMBH          510(k) NO: K110590(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE, MA     PHONE NO : 925 577 4616   
5160 HACIENDA DRIVE               SE DECISION MADE: 13-APR-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DRX-REVOLUTION MOBILE X-RAY SYSTEM
CARESTREAM HEALTH, INC.           510(k) NO: K120062(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
1049 W Ridge Rd                   SE DECISION MADE: 13-APR-12
Rochester NY 14615                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MECHANICAL WHEELCHAIR
AIKIN HEALTHCARE CO., LTD         510(k) NO: K120032(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 13-APR-12
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT
 
DEVICE: ALPHAPOINT IMAGING SOFTWARE
RADLOGICS, INC.                   510(k) NO: K120161(TRADITIONAL)
ATTN: MOSHE  BECKER               PHONE NO : 408 966 4874   
201 LA CANADA COURT               SE DECISION MADE: 13-APR-12
LOS GATOS CA 95023                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM
ACTIVIEWS LTD                     510(k) NO: K120300(TRADITIONAL)
ATTN: JOHN J SMITH, M.D., J.D.    PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 13-APR-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K120315(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 13-APR-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNGO CT DYNAMIC ANGIO
SIEMENS AG, MEDICAL SOLUTIONS     510(k) NO: K120331(TRADITIONAL)
ATTN: RALF  HOFMANN               PHONE NO : 499 191 188170
HENKESTRASSE 127                  SE DECISION MADE: 13-APR-12
ERLANGEN    GM D-91052            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PLYMOUTH THORACOLUMBAR PLATE SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K120092(SPECIAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 13-APR-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICRO I
CAREFUSION GERMANY 234 GMBH       510(k) NO: K113096(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 13-APR-12
HOECHBERG, BAVARIA    GM 97204    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K120135(TRADITIONAL)
ATTN: INGE  SCHEIDT               PHONE NO : 498 932 175515
EDISONSTRASSE 6                   SE DECISION MADE: 13-APR-12
UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPLOX II PEDICLE SCREW SYSTEM
CAPTIVA SPINE, INC                510(k) NO: K120292(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 13-APR-12
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUVASIVE NVJJB SYSTEM
NUVASIVE, INC.                    510(k) NO: K112717(TRADITIONAL)
ATTN: ELIAS  KETCHUM              PHONE NO : 858 320 4588   
7475 LUSK BLVD                    SE DECISION MADE: 13-APR-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
ANGIOSLIDE, LTD                   510(k) NO: K120805(SPECIAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
11925 WEST I-70 FRONTAGE RD NORTH SE DECISION MADE: 13-APR-12
CLAY ANSELMO CO 80033             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLEXITOUCH SYSTEM
TACTILE SYSTEMS TECHNOLOGY INC    510(k) NO: K120972(TRADITIONAL)
ATTN: PHILLIP  ROSE               PHONE NO : 612 355 5100   
1331 Tyler St NE Ste 200          SE DECISION MADE: 13-APR-12
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
ZONARE MEDICAL SYSTEMS, INC.      510(k) NO: K120703(TRADITIONAL)
ATTN: MARK  JOB                   PHONE NO : 763 682 4139   
420 NORTH BERNARDO AVENUE         SE DECISION MADE: 13-APR-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: DUAL HEATED INFANT VREATHING CIROUITS
FISHER & PAYKEL HEALTHCARE LTD.   510(k) NO: K103767(TRADITIONAL)
ATTN: ROBERT  PETRY               PHONE NO : 649 574 0123
15 MAURICE PAYKEL PLACE PO BOX 146SE DECISION MADE: 16-APR-12
AUCKLAND    NZ 1071               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
TRANSENTERIX, INC.                510(k) NO: K120403(TRADITIONAL)
ATTN: TAMMY B CARREA              PHONE NO : 919 765 8420   
635 DAVIS DRIVE SUITE 300         SE DECISION MADE: 16-APR-12
DURHAM NC 27560                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ESCALATE LAMINOPLASTY SYSTEM
STRYKER SPINE                     510(k) NO: K113802(TRADITIONAL)
ATTN: SIMONA  VOIC                PHONE NO : 908 522 3482   
2 PEARL COURT                     SE DECISION MADE: 16-APR-12
ALLENDALE NJ 07430                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
CODMAN & SHURTLEFF, INC.          510(k) NO: K120117(TRADITIONAL)
ATTN: MEGAN  HERMAN               PHONE NO : 508 828 3571   
325 PARAMOUNT DR.                 SE DECISION MADE: 16-APR-12
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OP SPINE SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K120291(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 16-APR-12
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUPERCATH Z3V
TOGO MEDIKIT CO., LTD.            510(k) NO: K112290(TRADITIONAL)
ATTN: FUMIAKI  KANAI              PHONE NO : 81 338 188577
4-1-17 HONGO                      SE DECISION MADE: 16-APR-12
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRANSCORP SPINAL ACCESS SYSTEM
TRANSCORP, INC.                   510(k) NO: K113352(TRADITIONAL)
ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 855 5375   
1000 100th St. SW SUITE F         SE DECISION MADE: 16-APR-12
Byron Center MI 49315             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
CARTICEPT MEDICAL INC             510(k) NO: K120830(SPECIAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3814   
6120 WINDWARD PARKWAY SUITE 220   SE DECISION MADE: 16-APR-12
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIAC
SORDINA S.P.A.                    510(k) NO: K110840(ABBREVIATED)
ATTN: BERTHOIN  CLAUDE            PHONE NO : 386 672 0450   
110 E. GRANADA BLVD SUITE 207     SE DECISION MADE: 17-APR-12
ORMOND BEACH FL 32176             510(k) STATEMENT
 
DEVICE: IND URINARY TRACT INFECTION (UTI) TEST STRIPS
IND DIAGNOSTIC, INC.              510(k) NO: K103037(TRADITIONAL)
ATTN: KAI  LOU                    PHONE NO : 604 522 1619
1629 FOSTERS WAY                  SE DECISION MADE: 17-APR-12
DELTA, B.C.    CA V3M 6S7         510(k) STATEMENT
 
DEVICE: AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
PEGAVISION CORPORATION            510(k) NO: K120028(TRADITIONAL)
ATTN: TONY  HSU                   PHONE NO : 886 332 98808
2F-1 NO.5, SHING YEH ST. SHAN DINGSE DECISION MADE: 17-APR-12
TAOYUAN    TW 33341               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
RIVERSTONE RESOURCES SDN. BHD.    510(k) NO: K112928(TRADITIONAL)
ATTN: CHONG  CHU MEE              PHONE NO : 603 602 83033
LOT 56, NO. 15, JALAN JASMIN 2    SE DECISION MADE: 17-APR-12
BUKIT BERUNTUNG, SELANGOR    MY 48510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RADIOGRAPHIC X-RAY SYSTEM
ORICH MEDICAL EQUIPMENT (TIANJIN C510(k) NO: K120034(TRADITIONAL)
ATTN: JUN  PENG                   PHONE NO : 305 609 4701   
6840 SW 45TH LN #5                SE DECISION MADE: 17-APR-12
MIAMI FL 33155                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3MENSIO WORKSTATION
PIE MEDICAL IMAGING B.V.          510(k) NO: K120367(TRADITIONAL)
ATTN: FLORIE  DANIELS             PHONE NO : 314 332 81328
BECANUSSTRAAT 13 D                SE DECISION MADE: 17-APR-12
MAASTRICHT    NL 6216 BX          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
HEALGEN SCIENTIFIC, LLC           510(k) NO: K111999(TRADITIONAL)
ATTN: YONGQUAN  WANG              PHONE NO : 713 661 6267   
5213 MAPLE STREET                 SE DECISION MADE: 17-APR-12
BELLAIRE TX 77401                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
THUNDER TIGER CORP.               510(k) NO: K112305(ABBREVIATED)
ATTN: JO  LEE                     PHONE NO : 886 423 591616
NO. 7, 6TH ROAD INDUSTRY PARK     SE DECISION MADE: 17-APR-12
TAICHUNG    TW 40755              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LOFRIC SINGLE USE URINARY CATHETER
ASTRA TECH AB                     510(k) NO: K113424(TRADITIONAL)
ATTN: FLOYD G LARSON              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 17-APR-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXTGEN ALTIUS OCT SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K113593(TRADITIONAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 17-APR-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTRAOSSEOUS FIXATION SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K120165(TRADITIONAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 17-APR-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TARGET DETACHABLE COIL
STRYKER NEUROVASCULAR             510(k) NO: K120850(SPECIAL)
ATTN: RHODA  SANTOS               PHONE NO : 510 413 2269   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 17-APR-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
NOVITAS MEDICAL, LLC              510(k) NO: K121001(TRADITIONAL)
ATTN: MARSHAL  FRYMAN             PHONE NO : 727 743 5040   
451 WEST LAMBERT ROAD SUITE 209   SE DECISION MADE: 17-APR-12
BREA CA 92821                     510(k) STATEMENT
                                  THIRD PARTY REVIEW
 
DEVICE: INZONE DETACHMENT SYSTEM
STRYKER                           510(k) NO: K120816(SPECIAL)
ATTN: MARA  CHOU                  PHONE NO : 510 413 2595   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 17-APR-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
DIAMOND DIAGNOSTICS, INC          510(k) NO: K120591(TRADITIONAL)
ATTN: KATHY  CRUZ                 PHONE NO : 508 429 0450   
333 Fiske St                      SE DECISION MADE: 17-APR-12
Holliston MA 01746                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WUNDER TEST
HIEN HELEN NGUYEN                 510(k) NO: K102428(TRADITIONAL)
ATTN: HIEN  NGUYEN                PHONE NO : 408 234 1368   
1810 OAKLAND RD., STE E           SE DECISION MADE: 18-APR-12
SAN JOSE CA 95131                 510(k) STATEMENT
 
DEVICE: AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
A.B. DENTAL DEVICES, LTD.         510(k) NO: K112440(TRADITIONAL)
ATTN: CHARLES  HURWITZ            PHONE NO : 972 392 33666
POB 367                           SE DECISION MADE: 18-APR-12
RAMAT HASHARON,    IS 47103       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ON CALL CHOSEN LANCING DEVICE
ACON LABORATORIES, INC.           510(k) NO: K113332(ABBREVIATED)
ATTN: AARON  FRIDAY               PHONE NO : 858 875 8057   
10125 Mesa Rim Road               SE DECISION MADE: 18-APR-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TWIN PEAKS LUMBAR CAGE
QUALGENIX LLC                     510(k) NO: K112696(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203 262 9340   
1 JACK'S HILL ROAD UNIT 3E        SE DECISION MADE: 18-APR-12
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZHENJIANG ASURE MECHANICAL WHEELCHAIR
ZHENJIANG ASSURE MEDICAL EQUIPMENT510(k) NO: K112816(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO. FU CHIUN STREET               SE DECISION MADE: 18-APR-12
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXUS TKO-6, LUER-ACTIVATED DEVICE
NEXUS MEDICAL, LLC                510(k) NO: K113398(TRADITIONAL)
ATTN: HEATHER  TURNER             PHONE NO : 913 451 2234   
11315 STRANG LINE ROAD            SE DECISION MADE: 18-APR-12
LENEXA KS 66215                   510(k) STATEMENT
 
DEVICE: SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
SYNERGEYES, INC.                  510(k) NO: K113586(ABBREVIATED)
ATTN: RICHARD E LIPPMAN           PHONE NO : 240 683 3738   
15825 SHADY GROVE ROAD SUITE 30   SE DECISION MADE: 18-APR-12
ROCKVILLE MD 20850                510(k) STATEMENT
 
DEVICE: JAZZY ELITE 6
PRIDE MOBILITY PRODUCT CORPORRATIO510(k) NO: K113488(SPECIAL)
ATTN: KIMBERLY  BLAKE             PHONE NO : 570 655 5574   
182 SUSQUEHANNA AVE.              SE DECISION MADE: 18-APR-12
EXETER PA 18643                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERSAFITCUP CC TRIO-ADDITIONAL LINERS
MEDACTA INTERNATIONAL             510(k) NO: K120531(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 18-APR-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MANTARAY GUIDEWIRES
BRIDGEPOINT MEDICAL               510(k) NO: K120881(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
13355 10TH AVE N, SUITE #110      SE DECISION MADE: 18-APR-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MODULAR PROXIMALLY FLUTED HIP STEM
SMITH & NEPHEW, INC.              510(k) NO: K113789(ABBREVIATED)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 399 5161   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 19-APR-12
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L&K BIOMED CO., LTD               510(k) NO: K120063(SPECIAL)
ATTN: HEE KYEONG  JOO             PHONE NO : 822 262 41475
#1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 19-APR-12
GEUMCHEON-GU, SEOUL    KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC.               510(k) NO: K112843(TRADITIONAL)
ATTN: BRODIE  PEDERSON            PHONE NO : 763 577 3180   
13700 1ST AVE. NORTH              SE DECISION MADE: 19-APR-12
PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRIMUS HEARING INSTRUMENT TEST UNIT
AUDITDATA A/S                     510(k) NO: K113831(TRADITIONAL)
ATTN: DAN  HAUGBOL                PHONE NO : 457 020 3124
BANESTROEGER 13                   SE DECISION MADE: 19-APR-12
TAASTRUP    DA DK-2630            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K120316(TRADITIONAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
11 North Ave                      SE DECISION MADE: 19-APR-12
Burlington MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
NEOMED, INC.                      510(k) NO: K120182(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978   
717 LAKEGLEN DR.                  SE DECISION MADE: 19-APR-12
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NOVAC 11
NEW RADIANT TECHNOLOGY S.P.A.     510(k) NO: K112286(TRADITIONAL)
ATTN: MAUREEN  O'CONNEL           PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 19-APR-12
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K111872(TRADITIONAL)
ATTN: TROY  QUANDER               PHONE NO : 520 229 4184   
1910 EAST INNOVATION PARK DR.     SE DECISION MADE: 19-APR-12
TUCSON AZ 85755                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SONICISION STERILIZATION TRAY
COVIDIEN                          510(k) NO: K112536(ABBREVIATED)
ATTN: DAVID M HORTON              PHONE NO : 303 530 6391   
5920 LONGBOW DR.                  SE DECISION MADE: 19-APR-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OLEA
EMERGO GROUP, INC.                510(k) NO: K120196(TRADITIONAL)
ATTN: KRISTI  GUSMAN              PHONE NO : 512 327 9997   
611 WEST 5TH ST THIRD FLOOR       SE DECISION MADE: 19-APR-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
GE VINGMED ULTRASOUND AS          510(k) NO: K120201(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DR., RP-2138    SE DECISION MADE: 19-APR-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EZONO 3000
LIFE-TECH, INC.                   510(k) NO: K120234(TRADITIONAL)
ATTN: SKIP  RIMER                 PHONE NO : 281 491 6600   
13235 N Promenade Blvd            SE DECISION MADE: 19-APR-12
Stafford TX 77477                 510(k) STATEMENT
 
DEVICE: NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
NOBLES MEDICAL TECHNOLOGIES II, IN510(k) NO: K113494(SPECIAL)
ATTN: MARIA  HATEGAN              PHONE NO : 714 427 0398   
17080 Newhope St                  SE DECISION MADE: 19-APR-12
Fountain Valley CA 92708          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PHILIPS MICRODOSE
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN510(k) NO: K120255(TRADITIONAL)
ATTN: GUSTAV  LINS                PHONE NO : 468 623 5200
Smidesvagen 5                     SE DECISION MADE: 19-APR-12
Solna    SW SE-171 41             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240
EIZO NANAO CORPORATION            510(k) NO: K120407(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 762 742468
153 SHIMOKASHIWANO                SE DECISION MADE: 19-APR-12
HAKUSAN    JA 924-8566            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESOLUTIONMD WEB
CALGARY SCIENTIFIC, INC.          510(k) NO: K120076(TRADITIONAL)
ATTN: KYLE  PETERSON              PHONE NO : 403 767 7945
SUITE 208, 1210 20TH AVENUE SE    SE DECISION MADE: 19-APR-12
CALGARY, ALBERTA    CA T2G 1M8    510(k) STATEMENT
 
DEVICE: OTIS-C PLUS
SCIENCE FOR BIOMATERIALS          510(k) NO: K120818(SPECIAL)
ATTN: DENIS  CLEMENT              PHONE NO : 330 562422 101
ZI DU MONGE                       SE DECISION MADE: 19-APR-12
LOURDES    FR F 65100             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K121010(TRADITIONAL)
ATTN: YANG  ZHAOHUI               PHONE NO : 867 558 1885640
BLDG. 9-13 BAIWANGXIN HIGH-TEC INDSE DECISION MADE: 19-APR-12
SHENZHEN    CH 518108             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: OPTIMA NM/CT 640
GE HEALTHCARE                     510(k) NO: K121019(TRADITIONAL)
ATTN: ELI  WERNER                 PHONE NO : 972 485 63666
4 HAYOZMA STREET                  SE DECISION MADE: 19-APR-12
TIRAT HACARMEL    IS 30200        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PRE-LOADED GOLD VISICOIL CK MARKER
RADIOMED CORPORATION              510(k) NO: K120859(SPECIAL)
ATTN: GORDON  ROBERTS             PHONE NO : 901 432 7202   
3150 STAGE POST DRIVE             SE DECISION MADE: 19-APR-12
Bartlett TN 38133                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K120699(TRADITIONAL)
ATTN: WU  ZICUI                   PHONE NO : 867 552 6582888
MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 19-APR-12
NANSHAN,SHENZHEN, P.R. CHINA    CH510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ATLAS PTA BALLOON DILATATION CATHETER
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K120971(TRADITIONAL)
ATTN: MEGAN  BROWN                PHONE NO : 480 379 2848   
1415 WEST 3RD ST.                 SE DECISION MADE: 19-APR-12
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: WHOLEY GUIDE WIRE SYSTEM
COVIDIEN LLC                      510(k) NO: K120863(TRADITIONAL)
ATTN: DAVID  RBERTSON             PHONE NO : 763 398 7000   
3033 CAMPUS DRIVE                 SE DECISION MADE: 19-APR-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: RIVAL PTA DILATATION CATHETER
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K120722(TRADITIONAL)
ATTN: MARK  JOB                   PHONE NO : 763 682 4139   
1415 WEST 3RD ST.                 SE DECISION MADE: 19-APR-12
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ORBIT
NATIONAL BIOMEDICAL LLC DBA QRS DI510(k) NO: K120880(SPECIAL)
ATTN: MARY KAY  JENSEN            PHONE NO : 763 559 8492   
6901 E. Fish Lake Road Suite 188  SE DECISION MADE: 19-APR-12
Maple Grove MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSTAPACS/INSTARISPACS
MEDDIFF TECHNOLOGIES PVT. LTD     510(k) NO: K120718(SPECIAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 19-APR-12
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
DIPPED PRODUCTS (THAILAND) LTD    510(k) NO: K111464(TRADITIONAL)
ATTN: L.G.S.  GUNAWARDANA         PHONE NO : 667 430 2100
82/2 MOO 9, TUMBON RATTAPUM AMPHURSE DECISION MADE: 19-APR-12
SONGKLA    TH 90220               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXCELSIOR XT-27 MICROCATHETER
STRYKER NEUROVASCULAR             510(k) NO: K113778(TRADITIONAL)
ATTN: YOKO Y ENRILE               PHONE NO : 510 413 2619   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 20-APR-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: EASYCARE TX SYSTEM (CONNEXUNS)
RESMED LTD.                       510(k) NO: K113780(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 20-APR-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MCKESSON ANESTHESIA CARE
MCKESSON TECHNOLOGIES INC.        510(k) NO: K113633(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 20-APR-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FENESTRATED NERVE BLOCK NEEDLE
IMD INC                           510(k) NO: K113662(TRADITIONAL)
ATTN: WALTER  ZOHMANN             PHONE NO : 800 824 8223   
PO BOX 510 9202 KELLY DRIVE       SE DECISION MADE: 20-APR-12
HUNTSVILLE UT 84317               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GORE DRYSEAL SHEATH
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K120428(SPECIAL)
ATTN: NANCY B LOWE                PHONE NO : 800 437 8181   
1505 N. FOURTH ST.                SE DECISION MADE: 20-APR-12
FLAGSTAFF AZ 86004                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BLUWHITE DIAMOND DENTAL BURS MODIFIED
BEAVERS DENTAL, DIV. SYBRON CANADA510(k) NO: K120037(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 20-APR-12
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
NEPHRON PHARMACEUTICALS CORP.     510(k) NO: K120051(TRADITIONAL)
ATTN: MARCUS  JULIANO             PHONE NO : 407 246 1389   
4121 34TH ST. S.W.                SE DECISION MADE: 20-APR-12
ORLANDO FL 32811 6475             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAPID PROGRAMMER
ST. JUDE MEDICAL                  510(k) NO: K113611(TRADITIONAL)
ATTN: TERI  GILIO                 PHONE NO : 972 526 8275   
6901 PRESTON ROAD                 SE DECISION MADE: 20-APR-12
PLANO TX 75024                    510(k) STATEMENT
 
DEVICE: NEO CR KNEE SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K120313(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 20-APR-12
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EARLOGIC OAE TESTER
EARLOGIC CORPORATION              510(k) NO: K112992(TRADITIONAL)
ATTN: SHIN KUK  YOO               PHONE NO : 714 313 7442   
8 EAST BROADWAY SUITE 611         SE DECISION MADE: 20-APR-12
SALY LAKE CITY UT 84111           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SALINE WOUND WASH
NANOPLAS, INC.                    510(k) NO: K112666(TRADITIONAL)
ATTN: RYAN  LYTLE                 PHONE NO : 847 228 6050   
2140 TOUHY AVE                    SE DECISION MADE: 20-APR-12
ELK GROVE VILLAGE IL 60007        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K111425(TRADITIONAL)
ATTN: SHERI  MUSGNUNG             PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 20-APR-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PALTOP DENTAL IMPLANT SYSTEM
PALTOP ADVANCED DENTAL SOLUTIONS L510(k) NO: K112795(TRADITIONAL)
ATTN: TAL  HAMMER-TOPAZ           PHONE NO : 972 462 71711
5 HASHITA STREET                  SE DECISION MADE: 20-APR-12
CAESAREA    IS IS                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ABBOTT NUTRITION ENTERAL FEEDINGS SET WITH SPIKERIGHT PLUS PROXIMAL CONNECTOR
ABBOT LABORATORIES                510(k) NO: K113719(TRADITIONAL)
ATTN: ELIZABETH M ZOLA            PHONE NO : 614 624 3316   
3300 STELZER ROAD                 SE DECISION MADE: 20-APR-12
COLUMBUS OH 43219 3034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
EIZO NANAO CORPORATION            510(k) NO: K113240(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627 42468
153 SHIMOKASHIWANO,               SE DECISION MADE: 20-APR-12
HAKUSAN, ISHIKAWA    JA 924-8566  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
MAUNA KEA TECHNOLOGIES            510(k) NO: K120208(SPECIAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 415 407 0223   
8 SNOWBERRY COURT                 SE DECISION MADE: 20-APR-12
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
DATASCOPE CORP., CARDIAC ASSIST DI510(k) NO: K120868(SPECIAL)
ATTN: HELDER A SOUSA              PHONE NO : 201 995 8710   
15 LAW DR.                        SE DECISION MADE: 20-APR-12
FAIRFIELD NJ 07004 0011           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
UNOMEDICAL A/S INFUSION DEVICES   510(k) NO: K120872(SPECIAL)
ATTN: JOHN M LINDSKOG             PHONE NO : 45 48 167000
AAHOLMVEJ 1-3, OSTED              SE DECISION MADE: 20-APR-12
LEJRE    DA DK-4320               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
PARCUS MEDICAL, LLC               510(k) NO: K120942(SPECIAL)
ATTN: PAUL  VAGTS                 PHONE NO : 920 746 2972   
839 SOUTH NEENAH AVE.             SE DECISION MADE: 20-APR-12
STURGEON BAY WI 54235             510(k) STATEMENT
 
DEVICE: NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
BIONESS, INC.                     510(k) NO: K120853(SPECIAL)
ATTN: KIM  TOMPKINS               PHONE NO : 661 362 5968   
25103 RYE CANYON LOOP             SE DECISION MADE: 20-APR-12
VALENCIA CA 91355                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLAT PANEL DETECTOR
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111824(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 23-APR-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
SYNERGETICS, INC                  510(k) NO: K113857(TRADITIONAL)
ATTN: GARY  OLIVEROS              PHONE NO : 636 794 5107   
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 23-APR-12
O'FALLON MO 63368                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HOME PREGNANCY TEST
NEWSCEN COAST BIO-PHARMACEUTICAL C510(k) NO: K112315(TRADITIONAL)
ATTN: CHANDRAVADAN  PATEL         PHONE NO : 805 581 4502   
2117 CLANEY CT                    SE DECISION MADE: 23-APR-12
SIMI VALLEY CA 93065              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VISIA
MEVIS MEDICAL SOLUTIONS AG        510(k) NO: K120207(TRADITIONAL)
ATTN: THOMAS E TYNES              PHONE NO : 262 691 9530   
N27 W24075 PAUL COURT SUITE 100   SE DECISION MADE: 23-APR-12
PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
BESTGEN BIOTECH CORP.             510(k) NO: K103230(TRADITIONAL)
ATTN: STEVEN  SHEN                PHONE NO : 886 282 272188
7F, NO 186, JIAN-YI ROAD          SE DECISION MADE: 24-APR-12
JUNG-HE, TAIPEI COUNTY    TW 235  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
CARDIOSOLUTIONS                   510(k) NO: K120086(TRADITIONAL)
ATTN: MICHELE  LUCEY              PHONE NO : 781 828 4400   
375 WEST ST.                      SE DECISION MADE: 24-APR-12
WEST BRIDGEWATER MA 02379         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K120452(TRADITIONAL)
ATTN: JOSEPH C GRIFFIN III        PHONE NO : 732 578 0060   
23 CHRISTOPHER WAY SUITE 103      SE DECISION MADE: 24-APR-12
EATONTOWN NJ 07724                510(k) STATEMENT
 
DEVICE: OSTEOMED WRIST PLATING SYSTEM
OSTEOMED LP                       510(k) NO: K120015(TRADITIONAL)
ATTN: SUZANNE  CHEANG             PHONE NO : 972 677 4779   
3885 Arapaho Rd                   SE DECISION MADE: 24-APR-12
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K120231(TRADITIONAL)
ATTN: HARRY  HAYES, PH.D          PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 24-APR-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BRAIN BIOPSY NEEDLE
AD-TECH MEDICAL INSTRUMENT CORP.  510(k) NO: K112094(TRADITIONAL)
ATTN: GARY J SYRING               PHONE NO : 608 877 2635   
800 LEVANGER LANE                 SE DECISION MADE: 24-APR-12
STOUGHTON WI 53589                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APLAN A.V. FISTULA NEEDLE SET
APLAN WELL ENTERPRISE CO., LTD    510(k) NO: K112734(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO. 58, FU CHIUN STREET           SE DECISION MADE: 24-APR-12
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK  HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
HAMILTON THORNE, INC.             510(k) NO: K120055(TRADITIONAL)
ATTN: DIARMAID H DOUGLAS-HAMILTON PHONE NO : 978 921 2050   
100 CUMMINGS CENTER-SUITE 465E    SE DECISION MADE: 24-APR-12
Beverly MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SLEEPWEAVER ELAN NASAL CPAP MASK
CIRCADIANCE LLC                   510(k) NO: K120757(SPECIAL)
ATTN: DAVID  GROLL                PHONE NO : 724 858 2837   
1060 CORPORATE LANE               SE DECISION MADE: 24-APR-12
EXPORT PA 15632                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APEX KIRSCHNER WIRES AND STEINMANN PINS
APEX TOOLS & ORTHOPEDICS CO.      510(k) NO: K121004(SPECIAL)
ATTN: HOLLACE  SAAS RHODES        PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 24-APR-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K120645(TRADITIONAL)
ATTN: RYAN  BORMANN               PHONE NO : 901 867 4409   
5677 AIRLINE RD.                  SE DECISION MADE: 24-APR-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICCOLO HDL-CAPILLARY TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K120662(TRADITIONAL)
ATTN: DENNIS M BLEILE             PHONE NO : 510 675 6515   
3240 WHIPPLE RD.                  SE DECISION MADE: 24-APR-12
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K120664(TRADITIONAL)
ATTN: DENNIS M BLEILE             PHONE NO : 510 675 6515   
3240 WHIPPLE RD.                  SE DECISION MADE: 24-APR-12
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MILAGRO INTERFERENCE SCREWS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K120589(TRADITIONAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 24-APR-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECTROCARDIOGRAPH
SHENZHEN CAREWELL ELECTRONICS CO.,510(k) NO: K113485(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 25-APR-12
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K113760(TRADITIONAL)
ATTN: VALERIE  GIAMBANCO          PHONE NO : 201 831 6275   
325 CORPORATE DRIVE               SE DECISION MADE: 25-APR-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
SINTEA PLASTEK, LLC               510(k) NO: K112611(SPECIAL)
ATTN: DANIELLE  WERNIKOWSKI       PHONE NO : 305 673 6226   
407 LINCOLN ROAD SUITE 10L        SE DECISION MADE: 25-APR-12
MIAMI BEACH FL 33139              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NASAL/EPISTAXIS PACK
COGENT THERAPEUTICS, LLC          510(k) NO: K113585(TRADITIONAL)
ATTN: ANNE  WORDEN                PHONE NO : 925 895 1200   
3637 BERNAL AVENUE                SE DECISION MADE: 25-APR-12
PLEASANTON CA 94566               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZOLL PROPAQ MD
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K112761(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 25-APR-12
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC.                510(k) NO: K120908(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 25-APR-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAREFUSION NICOLET EDX
CAREFUSION 209, INC.              510(k) NO: K120979(SPECIAL)
ATTN: CURTIS  TRUESDALE           PHONE NO : 608 829 8684   
1850 Deming Way                   SE DECISION MADE: 25-APR-12
Middleton WI 53562                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHARPS TANK REUSABLE SHARPS CONTAINER
REHRIG PACIFIC COMPANY            510(k) NO: K111085(ABBREVIATED)
ATTN: DAVID  OLMSTEAD             PHONE NO : 615 278 9292   
614 HUNTERS LANE                  SE DECISION MADE: 25-APR-12
BRENTWOOD TN 37027                510(k) STATEMENT
 
DEVICE: GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
GEO MEDICAL CO., LTD.             510(k) NO: K110835(TRADITIONAL)
ATTN: ALBERT  REGO                PHONE NO : 949 770 8710   
27001 LA PAZ ROAD SUITE 312       SE DECISION MADE: 26-APR-12
MISSION VIEJO CA 92691            510(k) STATEMENT
 
DEVICE: SOLITAIRE-C CERVICAL SPACER SYSTEM
EBI, LLC                          510(k) NO: K113796(TRADITIONAL)
ATTN: MARGARET  CROWE             PHONE NO : 973 299 9300   
100 INTERPACE PKWY.               SE DECISION MADE: 26-APR-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
CONVATEC INC                      510(k) NO: K112342(TRADITIONAL)
ATTN: KATRINA  FIEDLER            PHONE NO : 908 904 2541   
200 HEADQUARTERS PARK DRIVE       SE DECISION MADE: 26-APR-12
SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IROOT 100 MINI
S-DENTI CO., LTD.                 510(k) NO: K112153(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 26-APR-12
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
BIOLITEC SIA (LATVIA)             510(k) NO: K120437(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 26-APR-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEPUY PULSE CERVICAL CAGE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K120517(TRADITIONAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
325 PARAMOUNT DR                  SE DECISION MADE: 26-APR-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AERONEB PRO
AEROGEN LTD                       510(k) NO: K120939(SPECIAL)
ATTN: MARTHA  FOLAN               PHONE NO : 353 915 40400
GALWAY BUSINESS PARK, DANGAN      SE DECISION MADE: 26-APR-12
GALWAY    EI GALWAY               510(k) STATEMENT
 
DEVICE: C-QUR RPM MESH
ATRIUM MEDICAL CORP.              510(k) NO: K121070(SPECIAL)
ATTN: JOSEPH  DEPAOLO             PHONE NO : 603 880 1433   
5 Wentworth Dr                    SE DECISION MADE: 26-APR-12
HUDSON NH 03051                   510(k) STATEMENT
 
DEVICE: SECURACATH
INTERRAD MEDICAL INC              510(k) NO: K120935(SPECIAL)
ATTN: SEW-WAH  TAY                PHONE NO : 612 801 6782   
8401 73RD AVE NORTH STE 63        SE DECISION MADE: 27-APR-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3B RESMART CPAP AND AUTO CPAP SYSTEMS; BMC RESMART CPAP AND AUTO CPAP SYSTEMS
3B PRODUCTS, INC.                 510(k) NO: K110629(TRADITIONAL)
ATTN: NORMA F ESTRIN, PH.D.       PHONE NO : 301 279 2899   
9109 COPENHAVER DRIVE             SE DECISION MADE: 27-APR-12
POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
HEBEI CHANGSHENG PLASTIC PRODUCTS 510(k) NO: K113837(TRADITIONAL)
ATTN: RICHARD  LU                 PHONE NO : 861 064 796097
NO 99, HUANGJIN AVENUE, JULU COUNTSE DECISION MADE: 27-APR-12
XINGTAI, HEBEI PROVINCE    CH 0552510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K113707(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430 WAUKEGAN RD.                 SE DECISION MADE: 27-APR-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K113221(TRADITIONAL)
ATTN: JULIE  WHEELER              PHONE NO : 419 666 9455   
6750 WALES RD.                    SE DECISION MADE: 27-APR-12
NORTHWOOD OH 43619                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
GE MEDICAL SYSTEMS LUNAR          510(k) NO: K113286(TRADITIONAL)
ATTN: TRISHIA  DWYER              PHONE NO : 608 221 1551   
3030 Ohmeda Dr                    SE DECISION MADE: 27-APR-12
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CSM INTERNAL-R IMPLANT SYSTEM
CSM IMPLANT                       510(k) NO: K120043(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST UNIT B            SE DECISION MADE: 27-APR-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
WILSON-COOK MEDICAL, INC. / COOK E510(k) NO: K111895(TRADITIONAL)
ATTN: MARGE  WALLS-WALKER         PHONE NO : 336 744 0157   
4900 BETHANIA STATION ROAD        SE DECISION MADE: 27-APR-12
WINSTON-SALEM NC 27105            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: R3 XLPE LINERS
SMITH & NEPHEW, INC.              510(k) NO: K113848(TRADITIONAL)
ATTN: JOHN  CONNOR                PHONE NO : 901 399 5944   
1450 BROOKS RD.                   SE DECISION MADE: 27-APR-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K120341(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 27-APR-12
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
SHANDONG BAISHENG MEDICAL PRODUCTS510(k) NO: K112294(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 27-APR-12
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
NEPHROS, INC.                     510(k) NO: K112314(TRADITIONAL)
ATTN: GREG  COLLINS               PHONE NO : 201 343 5202   
41 GRAND AVE.                     SE DECISION MADE: 27-APR-12
RIVER EDGE NJ 07661               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOGATOR ADVANTAGE IRRIGATION PUMP
BYRNE MEDICAL, INC.               510(k) NO: K113119(TRADITIONAL)
ATTN: BRENT  GEIGER               PHONE NO : 763 553 3345   
14605 28TH AVENUE NORTH           SE DECISION MADE: 27-APR-12
MINNEAPOLIS MN 55442              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURGICASE CONNECT
MATERIALISE N.V.                  510(k) NO: K113599(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 321 639 6280
TECHNOLOGIELAAN 15                SE DECISION MADE: 27-APR-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCUDXA2
LONE OAK MEDICAL TECHNOLOGIES, LLC510(k) NO: K113616(TRADITIONAL)
ATTN: DAVID  COMLEY               PHONE NO : 215 230 7607   
3805 OLD EASTON ROAD              SE DECISION MADE: 27-APR-12
DOYLESTOWN PA 18902               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENESIS REUSABLE RIGID CONTAINER SYSTEM
CAREFUSION 2200, INC.             510(k) NO: K112535(TRADITIONAL)
ATTN: KATE  FULLER                PHONE NO : 847 473 7334   
1500 WAUKEGAN ROAD                SE DECISION MADE: 27-APR-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APTUS PROXIMAL HUMERUS SYSTEM
MEDARTIS AG                       510(k) NO: K120108(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 27-APR-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DRY MOUTH MOUTHWASH
DR. FRESH, INC.                   510(k) NO: K111250(TRADITIONAL)
ATTN: CAMILLE  THORNTON           PHONE NO : 757 224 0177   
MEDICAL DEVICES 144 RESEARCH DRIVESE DECISION MADE: 27-APR-12
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VOLUSON S6, VOLUSON S8
GE HEALTHCARE                     510(k) NO: K120741(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 27-APR-12
WAUWATOSA WI 53233                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES
CANOPUS MEDICAL SUPPLY CO., LTD.  510(k) NO: K120746(ABBREVIATED)
ATTN: GLORIA  CHANG               PHONE NO : 909 465 9188   
18709 GREEN BAT DR.,              SE DECISION MADE: 27-APR-12
ROWLAND HIGHS CA 91748            510(k) STATEMENT
 
DEVICE: PATHASSIST LIGHT FIBER
ENTELLUS MEDICAL, INC.            510(k) NO: K120962(SPECIAL)
ATTN: GARRETT P AHLBORG           PHONE NO : 763 463 7074   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 27-APR-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EPIFLO(R)
NEOGENIX, LLC                     510(k) NO: K120764(SPECIAL)
ATTN: SRINIVASAN  SARANGAPANI     PHONE NO : 781 702 6732   
3401 ENTERPRISE PKWY SUITE 340    SE DECISION MADE: 27-APR-12
BEACHWOOD OH 44122                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
SURGICAL APPLIANCE INDUSTRIES, INC510(k) NO: K121106(TRADITIONAL)
ATTN: GARY  PARSONS               PHONE NO : 800 888 0458   
3960 ROSSLYN DR.                  SE DECISION MADE: 27-APR-12
CINCINNATI OH 45209               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL;  ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
HORIBA ABX S.A.S.                 510(k) NO: K110530(ABBREVIATED)
ATTN: CAROLINE  FERRER            PHONE NO : 330 467 141843
PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 30-APR-12
MONTPELLIER CEDEX 4, HERAULT    FR510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EQUINOX RELIEVE
O-TWO MEDICAL TECHNOLOGIES, INC.  510(k) NO: K113687(TRADITIONAL)
ATTN: DAVID  ZHANG                PHONE NO : 905 677 9410
7575 KIMBEL ST.                   SE DECISION MADE: 30-APR-12
MISSISSAUGA    CA L5S 1C8         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
BAUSCH & LOMB, INC.               510(k) NO: K112909(TRADITIONAL)
ATTN: TRICIA  GARRETT             PHONE NO : 585 338 6706   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 30-APR-12
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: K2 MEDICAL VASCULAR CLAMPS
K2 MEDICAL GMBH & CO. KG          510(k) NO: K120492(TRADITIONAL)
ATTN: PETER  FETZER               PHONE NO : 497 462 200490
UNTER BUCHSTEIG 3A                SE DECISION MADE: 30-APR-12
TUTTLINGEN    GM 78532            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWERED MUSCLE STIMULATOR
VALMED, SA                        510(k) NO: K112148(TRADITIONAL)
ATTN: CARL  MAGNELL               PHONE NO : 412 720 36581
AVE DE TOURBILLON 34              SE DECISION MADE: 30-APR-12
SION, VALAIS    SZ CH 1950        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
INTUITIVE SURGICAL, INC.          510(k) NO: K120215(SPECIAL)
ATTN: KIM T SERVANCE              PHONE NO : 408 523 2100   
950 KIFER RD.                     SE DECISION MADE: 30-APR-12
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA
 
 
                                                 TOTAL 510(k)s THIS PERIOD   253                                     
                                                 TOTAL WITH SUMMARIES        230                                     
                                                 TOTAL WITH STATEMENTS        23