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U.S. Department of Health and Human Services

Medical Devices

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July 2011 510(k) Clearances

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


DEVICE: SP DYNAMICS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
FOTONA D.D.                       510(k) NO: K101306(TRADITIONAL)
ATTN: STOJAN  TROST               PHONE NO : 386 150 09100
STEGNE 7,                         SE DECISION MADE: 01-JUL-11
LJUBLJANA    SI 1210              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WELL-LIFE OTC EMS SYSTEM
WELL-LIFE HEALTHCARE LIMITED      510(k) NO: K102786(TRADITIONAL)
ATTN: JENNY  HSIEH                PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 01-JUL-11
YUNGHE CITY, TAIPEI COUNTY    TW 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
AMERICAN MEDICAL SYSTEMS          510(k) NO: K111118(SPECIAL)
ATTN: MONA  INMAN                 PHONE NO : 952 930 6204   
10700 BREN RD WEST                SE DECISION MADE: 01-JUL-11
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA POCT MANAGMENT SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K111029(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 01-JUL-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
ZIMMER, INC.                      510(k) NO: K110940(TRADITIONAL)
ATTN: CAROL  VIERLING             PHONE NO : 574 372 4964   
P.O. BOX 708                      SE DECISION MADE: 01-JUL-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT MARQUIS FLOW SWITCH
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K110643(TRADITIONAL)
ATTN: MARK  MULLANEY              PHONE NO : 353 917 03761
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 01-JUL-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
CASE MEDICAL, INC.                510(k) NO: K110682(TRADITIONAL)
ATTN: TANIA  LUPU                 PHONE NO : 201 313 1999   
19 EMPIRE BLVD                    SE DECISION MADE: 01-JUL-11
SOUTH HACKENSACK NJ 07606         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIGEN LOW PROFILE BONE SCREW
SMITH & NEPHEW, INC.              510(k) NO: K111025(TRADITIONAL)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 399 5161   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 01-JUL-11
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOUT TRACKING SYSTEM
ROBIN MEDICAL, INC.               510(k) NO: K111226(SPECIAL)
ATTN: RAYMOND  KELLY              PHONE NO : 603 595 0095   
56B SHADOWBROOK DRIVE             SE DECISION MADE: 01-JUL-11
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: ATLANTEAN TRIGGER NEBULIZER
ATLANTEAN CORPORATION             510(k) NO: K102719(TRADITIONAL)
ATTN: TOM  SHANKS                 PHONE NO : 951 506 2674   
29201 VIA NORTE                   SE DECISION MADE: 01-JUL-11
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLANT 2011
MATERIALISE DENTAL NV             510(k) NO: K110300(SPECIAL)
ATTN: PETER  VANDEPUT             PHONE NO : 32 16 39 60 39
TECHNOLOGIELAAN 15                SE DECISION MADE: 01-JUL-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
SIESTA MEDICAL, INC.              510(k) NO: K111179(SPECIAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
101 CHURCH STREET SUITE 3         SE DECISION MADE: 01-JUL-11
LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K103776(TRADITIONAL)
ATTN: LUBNA  SYED                 PHONE NO : 416 593 4323
439 UNIVERSITY AVE. SUITE 900     SE DECISION MADE: 01-JUL-11
TORONTO, ONTARIO    CA M5G 1Y8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
PRECISION MEDICAL, INC.           510(k) NO: K103563(TRADITIONAL)
ATTN: JAMES  PARKER               PHONE NO : 610 262 6090   
300 HELD DR.                      SE DECISION MADE: 01-JUL-11
NORTHAMPTON PA 18067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U2 HIP SYSTEM
UNITED ORTHOPEDIC CORP.           510(k) NO: K111546(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
NO 57 PARK AVE. 2 SCIENCE PARK    SE DECISION MADE: 01-JUL-11
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K102648(TRADITIONAL)
ATTN: LYNN  FU                    PHONE NO : 867 558 6090992
BLDG 11 LISHAN INDUSTRIAL PARK XINSE DECISION MADE: 01-JUL-11
SHENZHEN, GUANGDONG    CH 518052  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORTEX CO2 / ER:YAG LASER SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110897(TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 CITATION COURT                SE DECISION MADE: 01-JUL-11
HOMEWOOD AL 35209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTAL SHOULDER SYSTEM
SHOULDER INNOVATIONS, LLC         510(k) NO: K111596(SPECIAL)
ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 706 3903   
4670 FULTON STREET E              SE DECISION MADE: 05-JUL-11
ADA MI 49301                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRELESS MONITORING SYSTEM
CAREFUSION 303, INC.              510(k) NO: K110809(TRADITIONAL)
ATTN: SIMON  PEARMAIN             PHONE NO : 440 123 5438950
115 MITON PARK BUILDING 3         SE DECISION MADE: 05-JUL-11
ABINGDON,OXON    UK OX 14 4RZ     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
MAINE STANDARDS COMPANY, LLC      510(k) NO: K110880(TRADITIONAL)
ATTN: HOLLY  CRESSMAN             PHONE NO : 207 892 1300   
765 ROOSEVELT TRAIL               SE DECISION MADE: 05-JUL-11
WINDHAM ME 04062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
NOVABONE PRODUCTS, LLC            510(k) NO: K110925(TRADITIONAL)
ATTN: DAVID M GAISSER             PHONE NO : 386 462 7661   
13631 PROGRESS BLVD SUITE 600     SE DECISION MADE: 05-JUL-11
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SV DBS VRAIN ARRAY
MIDWEST RF, LLC                   510(k) NO: K111259(TRADITIONAL)
ATTN: HELMUT  KEIDI               PHONE NO : 262 367 6925   
P.O. BOX 348 1015 WALNUT RIDGE DRISE DECISION MADE: 05-JUL-11
HARTLAND WI 53029                 510(k) STATEMENT

DEVICE: ASCOM MOBILE MONITORING GATEWAY (MMG)
ASCOM (SWEDEN) AB                 510(k) NO: K111215(TRADITIONAL)
ATTN: TANIA  OTTEBRINK            PHONE NO : 46 31 559300
GRIMBODALEN 2, P.O. BOX 8783      SE DECISION MADE: 05-JUL-11
GOTEBORG    SW SE-402-76          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K092688(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 2 66258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 06-JUL-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
TRUE GLOVE FACTORY                510(k) NO: K111012(TRADITIONAL)
ATTN: FRANK  YANG                 PHONE NO : 865 363 775588
NO.6-1 XINGAN ROAD EAST, LINQU    SE DECISION MADE: 06-JUL-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: PARKER 500
ARJOHUNTLEIGH INC                 510(k) NO: K110994(ABBREVIATED)
ATTN: BRENDA  AMMONETTE           PHONE NO : 630 785 4885   
2349 WEST LAKE STREET SUITE 250   SE DECISION MADE: 06-JUL-11
ADDISON IL 60101                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIGURE 8 STERNOTOMY CLOSURE DEVICE
FIGURE 8 SURGICAL, INCORPORATED   510(k) NO: K110541(TRADITIONAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   
155-A MOFFETT PARK DRIVE, SUITE 21SE DECISION MADE: 06-JUL-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVLOK FENESTRATED SCREW SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K110280(SPECIAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 06-JUL-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATEAU SPACER SYSTEM
LIFE SPINE                        510(k) NO: K111569(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 06-JUL-11
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
GRAHAM MEDICAL TECHNOLOGIES, L.L.C510(k) NO: K111326(TRADITIONAL)
ATTN: JULIE  POWELL               PHONE NO : 512 327 9997   
611 WEST 5TH STREET, THIRD FLOOR  SE DECISION MADE: 06-JUL-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIPER SYSTEMS
JOHNSON & JOHNSON                 510(k) NO: K111571(SPECIAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 508 880 8395   
325 PARAMOUNT DR.                 SE DECISION MADE: 06-JUL-11
RAYNHAM MA 02767 0151             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED CONCENTRIC MICROCATHETER
CONCENTRIC MEDICAL, INC.          510(k) NO: K111619(SPECIAL)
ATTN: KIRSTEN  VALLEY             PHONE NO : 650 810 1707   
301 E. EVELYN AVE.                SE DECISION MADE: 06-JUL-11
MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K101381(TRADITIONAL)
ATTN: DONNA  MILLISKY             PHONE NO : 609 936 2454   
311 ENTERPRISE DR.                SE DECISION MADE: 07-JUL-11
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURO CHECK DEVICE WITH IO-FLEX WIRE
BAXANO, INC.                      510(k) NO: K110696(TRADITIONAL)
ATTN: EDWARD  SINCLAIR            PHONE NO : 408 514 2200   
655 RIVER OAKS PKWY               SE DECISION MADE: 07-JUL-11
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K103714(TRADITIONAL)
ATTN: MARY L ARMSTRONG            PHONE NO : 303 223 4336   
555 ZANG STREET, SUITE 100        SE DECISION MADE: 07-JUL-11
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURELIFT PROLAPSE SYSTEM
NEOMEDIC INTERNATIONAL            510(k) NO: K102815(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN          PHONE NO : 952 835 4018   
7307 GLOUCHESTER DRIVE            SE DECISION MADE: 07-JUL-11
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
FORA CARE INC.                    510(k) NO: K110044(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F, 5F, 6F, NO.127, WUGONG 2ND RD.SE DECISION MADE: 07-JUL-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APNEA RISK EVALUATION SYSTEM (ARES)
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K111194(SPECIAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
2511 FOX RIVER CIRCLE             SE DECISION MADE: 07-JUL-11
WAUKESHA WI 53189                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERO
MEDICAL PREDICTIVE SCIENCE CORP.  510(k) NO: K111601(SPECIAL)
ATTN: WILL  KING                  PHONE NO : 434 220 0714   
2246 IVY RD., SUITE 17            SE DECISION MADE: 08-JUL-11
CHARLOTTESVILLE VA 22903          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K111150(TRADITIONAL)
ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660 4201   
74 INVERNESS DRIVE EAST           SE DECISION MADE: 08-JUL-11
ENGLEWOOD CO 80112                510(k) STATEMENT

DEVICE: PAINFUSOR CATHETER
PLAN 1 HEALTH, S.R.L.             510(k) NO: K111031(TRADITIONAL)
ATTN: SIGI  CARON                 PHONE NO : 310 377 3069
2400 VIA CARILLO                  SE DECISION MADE: 08-JUL-11
PALOS VERDES ESTATES CA 90274     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS PRECICONTROL VARIA 3
ROCHE DIAGNOSTICS                 510(k) NO: K111506(TRADITIONAL)
ATTN: SARAH  BAUMANN              PHONE NO : 317 521 3952   
9115 HAGUE ROAD P.O. BOX 50410    SE DECISION MADE: 08-JUL-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHA2020
ANNIDIS HEALTH SYSTEMS CORP.      510(k) NO: K111531(TRADITIONAL)
ATTN: MICHAEL  MCDONNELL          PHONE NO : 613 596 1800
2650 QUEENSVIEW DRIVE SUITE 245   SE DECISION MADE: 08-JUL-11
OTTAWA, ONTARIO    CA K2B 8H6     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MEDIOSTAR NEXT
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K111851(SPECIAL)
ATTN: ANTJE  KATZER               PHONE NO : 493 641 7700309
BRUESSELER STR. 10                SE DECISION MADE: 08-JUL-11
JENA    GM 07747                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL FACTOR VIII DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO.    510(k) NO: K110237(TRADITIONAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4350   
180 HARTWELL ROAD                 SE DECISION MADE: 08-JUL-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DP-6900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K111435(SPECIAL)
ATTN: SUSAN D GOLDSTEIN           PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 08-JUL-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT
ARAGON SURGICAL INC.              510(k) NO: K110824(TRADITIONAL)
ATTN: ALAN  CURTIS                PHONE NO : 925 209 7174   
3617 SCOTT STREET                 SE DECISION MADE: 11-JUL-11
SAN FRANCISCO CA 94123            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
CARTICEPT MEDICAL INC             510(k) NO: K101194(TRADITIONAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3814   
6120 WINDWARD PARKWAY SUITE 220   SE DECISION MADE: 11-JUL-11
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
SHANDONG YINGHONG MEDICAL PRODUCTS510(k) NO: K110981(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 12-JUL-11
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYFIT SILKGEL NASAL MASK
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K110884(SPECIAL)
ATTN: RALF  EGENOLF               PHONE NO : 49 405 4702370
KRONSAALSWEG 40                   SE DECISION MADE: 12-JUL-11
HAMBURG    GM 22525               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO FIXATION SYSTEM
SYNOVIS ORTHOPEDIC & WOUNDCARE    510(k) NO: K110538(TRADITIONAL)
ATTN: AMY  BOUCLY                 PHONE NO : 949 502 3240   
6 Jenner, Suite 150               SE DECISION MADE: 12-JUL-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERI-DENT, STERI-SURE
CPAC, INC.                        510(k) NO: K094026(TRADITIONAL)
ATTN: JEFFREY  CRANE              PHONE NO : 585 382 3223   
2364 LEICESTER RD. P.O. BOX 175   SE DECISION MADE: 12-JUL-11
LEICESTER NY 14481 0175           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
MEDICA CORPORATION                510(k) NO: K111036(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 12-JUL-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: TITAN TI SUTURE ANCHOR SYSTEM
ARTHROCARE CORP.                  510(k) NO: K111397(SPECIAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224   
680 VAQUEROS AVE.                 SE DECISION MADE: 12-JUL-11
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOSORB RESORBABLE PINS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K111077(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 12-JUL-11
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ELLIPSE TECHNOLOGIES, INC.        510(k) NO: K101997(TRADITIONAL)
ATTN: JOHN  MCINTYRE              PHONE NO : 949 837 3600   
13844 ALTON PARKWAY SUITE 130     SE DECISION MADE: 12-JUL-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOLOGIX AFX INTRODUCER SYSTEM
ENDOLOGIX, INC.                   510(k) NO: K111747(SPECIAL)
ATTN: JANET M FAULS               PHONE NO : 949 595 7203   
11 STUDEBAKER                     SE DECISION MADE: 12-JUL-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
SMITH & NEPHEW, INC.              510(k) NO: K110670(TRADITIONAL)
ATTN: DAVID  HENLEY               PHONE NO : 901 399 6487   
1450 BROOKS RD.                   SE DECISION MADE: 12-JUL-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLANAS AVALON POSTERIOR FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K111076(TRADITIONAL)
ATTN: KARLA  SCHAFFNER            PHONE NO : 760 494 6739   
5818 EL CAMINO REAL               SE DECISION MADE: 12-JUL-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
MEDICA CORP.                      510(k) NO: K101089(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 13-JUL-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: CARDIAC SCANNER AND PROCESSING SYSTEM
SPECTRUM DYNAMICS (ISRAEL) LTD.   510(k) NO: K110507(TRADITIONAL)
ATTN: ILAN  SHARON                PHONE NO : 972 53 8704904
1 HA'RAKEFET ST.                  SE DECISION MADE: 13-JUL-11
ZICHRON YAACOV    IS 30900        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES
W.A. RUBBERMATE CO., LTD.         510(k) NO: K110418(TRADITIONAL)
ATTN: TERENCE LIM SIN  KOOI       PHONE NO : 662 318 9442
NONGMAIDAENG                      SE DECISION MADE: 13-JUL-11
A. MAUNG, CHONBURI    TH 20000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX KNEE SYSTEM, APEX ALL POLY TIBIA
OMNILIFE SCIENCE INC.             510(k) NO: K111062(TRADITIONAL)
ATTN: CHRISTINE  NASSIF           PHONE NO : 774 226 1871   
50 O'CONNELL WAY SUITE #10        SE DECISION MADE: 13-JUL-11
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANOURA 18S
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K111231(TRADITIONAL)
ATTN: FUMIAKI  KANAI              PHONE NO : 011 813 38188577
4-1-17 HONGO, BUNKYO-KU           SE DECISION MADE: 13-JUL-11
TOKYO    JA 113-0033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANTEVIEW
SEHYUN CO., LTD.                  510(k) NO: K111312(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK STREET UNIT J        SE DECISION MADE: 13-JUL-11
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECG PEN
MERIDIAN DYNAMICS BIOMEDICAL, INC 510(k) NO: K103077(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N. BOLDT DRIVE               SE DECISION MADE: 13-JUL-11
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLAS SPINE PEDICLE SCREW SYSTEM
ATLAS SPINE INC.                  510(k) NO: K110842(SPECIAL)
ATTN: JEANNETTE G DAILEY          PHONE NO : 561 354 4319   
1555 JUPITER PARK DR., STE. 4     SE DECISION MADE: 13-JUL-11
JUPITER FL 33458                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VACCESS PTA DILATATION CATHETER
C.R. BARD, INC.                   510(k) NO: K111850(TRADITIONAL)
ATTN: CANDACE  WADE               PHONE NO : 480 303 2662   
1625 WEST 3RD ST                  SE DECISION MADE: 13-JUL-11
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K111652(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 13-JUL-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCUPRO MESSENGER BALLOON CATHETER
CARDIOSOLUTIONS INC               510(k) NO: K094048(TRADITIONAL)
ATTN: MICHELE  LUCEY              PHONE NO : 781 344 0801   
75 MILL STREET                    SE DECISION MADE: 14-JUL-11
STOUGHTON MA 02072                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
KOON SENG SDN.BHD                 510(k) NO: K110960(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 14-JUL-11
GREENWOOD VILLAGE CO 80121        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
AM USA                            510(k) NO: K111034(SPECIAL)
ATTN: KAREN  THOMISON             PHONE NO : 615 833 2633   
5209 LINDBAR DRIVE SUITE 640      SE DECISION MADE: 14-JUL-11
NASHVILLE TN 37167                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K111240(ABBREVIATED)
ATTN: ELIZABETH  DENG             PHONE NO : 909 465 9188   
5748 EAGLEWOOD PLACE              SE DECISION MADE: 14-JUL-11
RANCHO CUCAMONGA CA 91739         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARA
DIAGNOS, INC                      510(k) NO: K110869(TRADITIONAL)
ATTN: ARON  SHAPIRO               PHONE NO : 978 685 8900   
300 BRICKSTONE SQUARE             SE DECISION MADE: 14-JUL-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOFUSE DENTAL IMPLANT SYSTEM
DYNAMIC INNOVATIONS INC.          510(k) NO: K110577(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE STREET UNIT B       SE DECISION MADE: 14-JUL-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SYRINGES AND NEEDLES
TIGER MEDICAL PRODUCTS LTD        510(k) NO: K110697(TRADITIONAL)
ATTN: DAVID  WANG                 PHONE NO : 862 163 866300
1 HUAIHAI ZHONG ROAD LIU LIN TOWERSE DECISION MADE: 14-JUL-11
SHANGHAI    CH 200021             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
HOWMEDICA OSTEONICS CORP. DBA STRY510(k) NO: K111065(TRADITIONAL)
ATTN: CALUDIA  WIESEMANN          PHONE NO : 
325 CORPORATE DRIVE               SE DECISION MADE: 14-JUL-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
NEPHROS, INC.                     510(k) NO: K110285(SPECIAL)
ATTN: JAMES  SUMMERTON            PHONE NO : 201 343 5202   
41 GRAND AVE.                     SE DECISION MADE: 14-JUL-11
RIVER EDGE NJ 07661               510(k) STATEMENT

DEVICE: SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
APOTHECARY PRODUCTS, INC.         510(k) NO: K111856(TRADITIONAL)
ATTN: JAMES  JENKINS              PHONE NO : 952 808 8364   
11750 12TH AVE. SOUTH             SE DECISION MADE: 14-JUL-11
BURNSVILLE MN 55337               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OPIATE ENZYME IMMUNOASSAY
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K110298(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 ALMANOR AVENUE                SE DECISION MADE: 15-JUL-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
ANDON MEDICAL CO., LTD.           510(k) NO: K093755(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 287 612426
NO. 04-23-3 AIRPORT INDUSTRIAL PARSE DECISION MADE: 15-JUL-11
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODY ANALYSIS SCALE, MODEL BG 17
SHENZHEN HEALTHCARE ELECTRONIC TEC510(k) NO: K110928(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 15-JUL-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
SHANDONG ZHANPENG MEDICAL PRODUCTS510(k) NO: K110857(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 15-JUL-11
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRO FAMILY OF MANUAL WHEELCHAIRS
OTTO BOCK HEALTHCARE, LP          510(k) NO: K111045(TRADITIONAL)
ATTN: WILLIAM  KABITZ             PHONE NO : 763 553 9464   
2 CARLSON PKWY., SUITE 100        SE DECISION MADE: 15-JUL-11
MINNEAPOLIS MN 55447 4467         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
LIMACORPORATE S.P.A.              510(k) NO: K110847(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 15-JUL-11
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACG-8511 PORTABLE ECG MONITOR
ANDON HEALTH CO.,LTD              510(k) NO: K110328(TRADITIONAL)
ATTN: LIU  YI                     PHONE NO : 862 260 526161
NO 3,  JINPING STREET YA AN RD NANSE DECISION MADE: 15-JUL-11
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
ASTORIA-PACIFIC,INC.              510(k) NO: K102643(TRADITIONAL)
ATTN: JASON C REYNOLDS            PHONE NO : 503 657 3010   
15130 S.E. 82ND DR.               SE DECISION MADE: 15-JUL-11
CLACKAMAS OR 97015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
BEIJING RONGRUI-CENTURY SCIE. & TE510(k) NO: K103685(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 15-JUL-11
SHANGAHI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH GIBRALT SPINAL SYSTEM
EXACTECH, INC.                    510(k) NO: K110197(TRADITIONAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 15-JUL-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES
GX CORPORATION SDN BHD            510(k) NO: K111328(TRADITIONAL)
ATTN: GANESAN  SUPIRAMUNIAM       PHONE NO : 603 329 11600
LOT 6487, BATU 5 3/4, SEMENTA JALASE DECISION MADE: 15-JUL-11
KLANG, SELANGOR    MY 42100       510(k) STATEMENT

DEVICE: WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K111560(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 15-JUL-11
GAITHERSBRUG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-SCAN
ESAOTE, S.P.A.                    510(k) NO: K111803(SPECIAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 15-JUL-11
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
ACCESS SCIENTIFIC, INC.           510(k) NO: K111417(SPECIAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
12526 HIGH BLUFF DRIVE SUITE 360  SE DECISION MADE: 15-JUL-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
VOLCANO CORPORATION               510(k) NO: K111706(SPECIAL)
ATTN: JWALA  JAWHARKAR            PHONE NO : 916 281 2925   
2870 KILGORE RD.                  SE DECISION MADE: 15-JUL-11
RANCHO CORDOVA CA 95670           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 9
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K111864(TRADITIONAL)
ATTN: YUCHI  CHU                  PHONE NO : 425 949 4907   
SUITE 226, 10604 NE 38TH PLACE    SE DECISION MADE: 15-JUL-11
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FALCON
VIASONIX LTD.                     510(k) NO: K111416(TRADITIONAL)
ATTN: WILLIAM  STERN              PHONE NO : 914 376 5200   
1 ODELL PLAZA                     SE DECISION MADE: 15-JUL-11
YONKERS NY 10701                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
MEDIVANCE, INC.                   510(k) NO: K110956(TRADITIONAL)
ATTN: LYNNE  ARONSON              PHONE NO : 303 926 1917   
321 SOUTH TAYLOR AVE, STE 200     SE DECISION MADE: 18-JUL-11
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ELECTROSURGICAL INSTRUMENT
ASCENT HEALTHCARE SOLUTIONS       510(k) NO: K110189(TRADITIONAL)
ATTN: AMANDA  BABCOCK             PHONE NO : 480 763 5376   
10232 SOUTH 51ST STREET           SE DECISION MADE: 18-JUL-11
PHOENIX AZ 85044                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANDELA GENTLELASE FAMILY OF LASERS
CANDELA CORP.                     510(k) NO: K111144(TRADITIONAL)
ATTN: SCOTT  BLOOD                PHONE NO : 508 358 7400   
530 BOSTON POST ROAD              SE DECISION MADE: 18-JUL-11
WAYLAND MA 01778                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ENDOSCOPIC TROCARS
STERILMED, INC.                   510(k) NO: K111002(TRADITIONAL)
ATTN: GARRETT  AHLBORG            PHONE NO : 763 488 3483   
11400 73RD AVE. NORTH             SE DECISION MADE: 18-JUL-11
MAPLE GROVE MN 55369 5562         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOMAIN SURGICAL SYSTEM
DOMAIN SURGICAL, INC.             510(k) NO: K110439(TRADITIONAL)
ATTN: CURTIS  JENSEN              PHONE NO : 801 924 4958   
1370 SOUTH 2100 EAST              SE DECISION MADE: 18-JUL-11
SALT LAKE SITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSTONE R SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K103731(TRADITIONAL)
ATTN: THAO  PHAN                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 18-JUL-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEL-CAT
TAKARA BELMONT CORP.              510(k) NO: K101181(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO COURT                SE DECISION MADE: 19-JUL-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
IMMUNO-MYCOLOGICS, INC.           510(k) NO: K101407(TRADITIONAL)
ATTN: SEAN K BAUMAN, PH.D         PHONE NO : 405 360 4669   
2700 TECHNOLOGY PLACE             SE DECISION MADE: 19-JUL-11
NORMAN OK 73071                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
FUJIREBIO DIAGNOSTICS, INC.       510(k) NO: K103676(TRADITIONAL)
ATTN: DIANA  LYN DICKSON          PHONE NO : 610 240 3917   
201 GREAT VALLEY PKWY.            SE DECISION MADE: 19-JUL-11
MALVERN PA 19355 1307             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI TELEMETRY SYSTEM
WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K110556(TRADITIONAL)
ATTN: AGATA  SMIEJA               PHONE NO : 410 456 0329   
8880 GOMAN ROAD                   SE DECISION MADE: 19-JUL-11
LAUREL MD 20723 5800              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE VESSEL CANNULA
MEDLINE, INDUSTRIES, INC.         510(k) NO: K111147(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 19-JUL-11
MUNDELEIN IL 60060                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD INSYTE AUTOGUARD BC
BECTON DICKINSON & CO.            510(k) NO: K110443(TRADITIONAL)
ATTN: RAND  PUGMIRE               PHONE NO : 801 565 2550   
9450 SOUTH STATE STREET           SE DECISION MADE: 19-JUL-11
SANDY UT 84070                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTROPY EASYFIT SENSOR
GE HEALTHCARE                     510(k) NO: K103129(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 781 449 8685   
86 PILGRIM ROAD                   SE DECISION MADE: 19-JUL-11
NEEDHAM MA 02492                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOLPHIN 3 FLUID MANAGEMENT SYSTEM
GYRUS ACMI, INC.                  510(k) NO: K110852(TRADITIONAL)
ATTN: GRAHAM  BAILLIE             PHONE NO : 508 804 2738   
136 TURNPIKE RD.                  SE DECISION MADE: 19-JUL-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA XR120
GE MEDICAL SYSTEMS, LLC           510(k) NO: K111304(SPECIAL)
ATTN: NIDHI  CHAUDHARY            PHONE NO : 414 721 2899   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 19-JUL-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXXSD SYSTEM
SPINE WAVE, INC.                  510(k) NO: K111469(SPECIAL)
ATTN: DENISE  DUCHENE             PHONE NO : 203 712 1847   
3 ENTERPRISE DR SUITE 210         SE DECISION MADE: 19-JUL-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
WILSON-COOK MEDICAL INC.          510(k) NO: K111495(TRADITIONAL)
ATTN: MARGE  WALLS-WALKER         PHONE NO : 336 744 0157   
4900 Bethania Station Rd          SE DECISION MADE: 19-JUL-11
WINSTON-SALEM NC 27105            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURON MAX SYSTEM
PENUMBRA, INC.                    510(k) NO: K111380(SPECIAL)
ATTN: MICHAELA  MAHL              PHONE NO : 510 748 3288   
1351 HARBOR BAY PARKWAY           SE DECISION MADE: 19-JUL-11
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL90
RADIOMETER MEDICAL APS            510(k) NO: K111897(SPECIAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 382 73114
AAKANDEVEJ 21                     SE DECISION MADE: 19-JUL-11
COPENHAGEN    DA 2100             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILEDIAGNOST WDR
SEDECAL SA                        510(k) NO: K111725(SPECIAL)
ATTN: JENNIFER  CARTLEDGE         PHONE NO : 864 506 0097   
409 WOODRIDGE DR                  SE DECISION MADE: 19-JUL-11
SENECA SC 29672                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATEAU SPACER SYSTEM
LIFE SPINE, INC                   510(k) NO: K111835(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 19-JUL-11
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
LPL (HUI ZHOU) GLOVE CO., LTD.    510(k) NO: K111598(ABBREVIATED)
ATTN: CAMILLE D THORNTON          PHONE NO : 757 224 0177   
144 RESEARCH DRIVE                SE DECISION MADE: 20-JUL-11
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVIE A1C TEST SYSTEM
MEC DYNAMICS CORP                 510(k) NO: K093548(TRADITIONAL)
ATTN: EMMANUEL  MPOCK             PHONE NO : 408 428 9721   
90 ROSE ORCHARD WAY               SE DECISION MADE: 20-JUL-11
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRAG LATERAL FLOW ASSAY (CRAG LFA)
IMMUNO-MYCOLOGICS, INC.           510(k) NO: K102286(TRADITIONAL)
ATTN: SEAN  BAUMAN                PHONE NO : 405 360 4669   
2700 TECHNOLOGY PLACE             SE DECISION MADE: 20-JUL-11
NORMAN OK 73071                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERI-DENT, STERI-SURE
CPAC, INC.                        510(k) NO: K110867(TRADITIONAL)
ATTN: JEFFREY S CRANE             PHONE NO : 585 383 3223   
2364 LEICESTER RD. P.O. BOX 175   SE DECISION MADE: 20-JUL-11
LEICESTER NY 14481 0175           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA CT660
GE MEDICAL SYSTEMS, LLC           510(k) NO: K110227(SPECIAL)
ATTN: TRACEY  ORTIZ               PHONE NO : 414 544 3206   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 20-JUL-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEVOFLURANE VAPORIZER ADAPTOR
PIRAMAL CRITCAL CARE, INC (FORMERL510(k) NO: K110608(TRADITIONAL)
ATTN: JAMIE  KELLER               PHONE NO : 610 974 9760   
50 COBHAM DRIVE                   SE DECISION MADE: 20-JUL-11
ORCHARD PARK NY 14127             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMMUNIFY PACS VIEWER
FLYING SQUIRREL STORAGE LLC       510(k) NO: K110797(TRADITIONAL)
ATTN: CHRIS  RELYEA               PHONE NO : 646 526 7111   
160 W 71ST, FLOOR 18              SE DECISION MADE: 20-JUL-11
NEW YORK NY 10023                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
ENCORE MEDICAL, L.P.              510(k) NO: K111061(SPECIAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6225   
9800 METRIC BLVD.                 SE DECISION MADE: 20-JUL-11
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMI IMPLANT; MINI HEMI IMPLANT
VILEX, INC.                       510(k) NO: K102401(TRADITIONAL)
ATTN: SYLVIA  SOUTHARD            PHONE NO : 931 474 7550   
111 MOFFITT STREET                SE DECISION MADE: 20-JUL-11
MCMINNVILLE TN 37110              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K103745(TRADITIONAL)
ATTN: WENDY A MCMANUS             PHONE NO : 973 889 4415   
1500 LITTLETON ROAD               SE DECISION MADE: 20-JUL-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE DATEX-OHMEDA AISYS
DATEX-OHMEDA, INC.                510(k) NO: K110213(TRADITIONAL)
ATTN: JIM  RASKOB                 PHONE NO : 608 221 1551   
PO BOX 7550 3030 OHMEDA DR.       SE DECISION MADE: 20-JUL-11
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR
EDAN INSTRUMENTS, INC.            510(k) NO: K110922(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6899197
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 20-JUL-11
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP CANNULATED SCREWS
AAP IMPLANTATE AG                 510(k) NO: K111316(SPECIAL)
ATTN: MARC  SEEGERS               PHONE NO : 49 30 75019192
LORENZWEG 5                       SE DECISION MADE: 20-JUL-11
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIDITE ZIRCONIA DENTAL CERAMICS
QINHUANGDAO AIDITE HIGH-TECHNICAL 510(k) NO: K111291(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 20-JUL-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN (R) MICROSTREP PLUS (R) PANELS
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K111205(TRADITIONAL)
ATTN: SHANNON  POPSON             PHONE NO : 916 374 3330   
1584 ENTERPRISE BLVD.             SE DECISION MADE: 20-JUL-11
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXXENT RADIATION SHIELD - RIGID
XOFT, AN ICAD COMPANY             510(k) NO: K111299(TRADITIONAL)
ATTN: STEVE  LIN                  PHONE NO : 408 419 2300   
345 POTRERO AVENUE                SE DECISION MADE: 20-JUL-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
ARTHROCARE CORP.                  510(k) NO: K111399(SPECIAL)
ATTN: LAURA  KASPEROWICZ          PHONE NO : 949 585 2406   
15285 ALTON PARKWAY SUITE 200     SE DECISION MADE: 20-JUL-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHWAY MODEL 07XXXX
CUSTOM SPINE                      510(k) NO: K111774(SPECIAL)
ATTN: SAAD  ATTIYAH               PHONE NO : 973 808 0019   
1140 PARSIPPANY BLVD, SUITE 20    SE DECISION MADE: 20-JUL-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
ICOTEC                            510(k) NO: K100305(TRADITIONAL)
ATTN: BARBARA  ATZENHOEFER STEGMEIPHONE NO : 763 588 9836   
4050 OLSON MEMORIAL HIGHWAY SUITE SE DECISION MADE: 21-JUL-11
MINNEAPOLIS MN 55422              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESYS SPINE TILOCK SYSTEM
GENESYS SPINE                     510(k) NO: K103671(SPECIAL)
ATTN: BRIAN J BERGERON            PHONE NO : 512 381 7071   
1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 21-JUL-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110970(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 21-JUL-11
RD. HAI DI,  BEIJING    CH 100083 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CI-SNAP WOUND CARE SYSTEM
SPIRACUR, INC.                    510(k) NO: K111006(TRADITIONAL)
ATTN: SARAH  CANIO                PHONE NO : 408 400 0856   
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 21-JUL-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEPMINDER BREATHING FREQUENCY INDICATOR
BIANCAMED LIMITED                 510(k) NO: K103631(TRADITIONAL)
ATTN: PAUL  PHILLIPS              PHONE NO : 353 171 63755
NOVAUCD, BELFIELD INNOVATION P UNISE DECISION MADE: 21-JUL-11
BELFIELD, DUBLIN    EI 4          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPLOR RADIAL HEAD PLATING SYSTEM
BIOMET, INC.                      510(k) NO: K110201(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 21-JUL-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFUSION SET FOR POWERPICC SOLO 2 CATHETER
C.R. BARD, INC.                   510(k) NO: K102405(TRADITIONAL)
ATTN: LYNN M KIRCHOFF             PHONE NO : 801 522 5636   
605 NORTH 5600 WEST               SE DECISION MADE: 21-JUL-11
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COREN TOTAL HIP SYSTEM
CORENTEC CO., LTD                 510(k) NO: K103431(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 21-JUL-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K103831(TRADITIONAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 21-JUL-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
OBI BIOLOGICS, INC.               510(k) NO: K101453(TRADITIONAL)
ATTN: DUSTYN  WEBB                PHONE NO : 806 796 1923   
4620 71ST STREET, BLDG 79         SE DECISION MADE: 21-JUL-11
LUBBOCK TX 79424                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110966(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 21-JUL-11
RD. HAI DI    CH 100083           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
KCI USA, INC.                     510(k) NO: K111280(TRADITIONAL)
ATTN: MARGARET  MARSH             PHONE NO : 210 255 6481   
6203 FARINON DR.                  SE DECISION MADE: 21-JUL-11
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DSC/ALF SPINAL SYSTEM
SINTEA PLASTEK, LLC               510(k) NO: K101886(TRADITIONAL)
ATTN: DANIELLE  WERNIKOWSKI       PHONE NO : 305 673 6226   
407 LINCOLN ROAD SUITE 101        SE DECISION MADE: 21-JUL-11
MIAMI BEACH FL 33139              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K110320(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 21-JUL-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS T3 CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K111552(TRADITIONAL)
ATTN: KELLY  FRENCH               PHONE NO : 317 521 3208   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 21-JUL-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
ZYGA TECHNOLOGY, INC.             510(k) NO: K111801(TRADITIONAL)
ATTN: DIANE  BRINZA               PHONE NO : 612 455 1061   
700 10TH AVENUE SOUTH, SUITE 400  SE DECISION MADE: 21-JUL-11
MINNEAPOLIS MN 55415              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REXIOUS SPINAL FIXATION SYSTEM
DIO MEDICAL CO., LTD.             510(k) NO: K111362(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 21-JUL-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METASURG DIGIFUSE IMPLANT
METASURG                          510(k) NO: K111536(TRADITIONAL)
ATTN: JOSHUA  SCOTT               PHONE NO : 281 398 5656   
16350 PARK TEN PL., SUITE 101     SE DECISION MADE: 21-JUL-11
HOUSTON TX 77084                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
ANGIOSLIDE, LTD                   510(k) NO: K111750(SPECIAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
11925 WEST I-70 FRONTAGE RD NORTH SE DECISION MADE: 21-JUL-11
CLAY ANSELMO CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAESTRO WRIST PLATING SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K110271(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 BELL DRIVE                     SE DECISION MADE: 22-JUL-11
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFLIP GASTRIC TUBE
CROSPON, LTD.                     510(k) NO: K110529(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 22-JUL-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACRYLIC HERBST APPLIANCE
EMBASSY DENTAL LABORATORY         510(k) NO: K111009(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 22-JUL-11
CHESTERLAND OH 44026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ E9
GE HEALTHCARE                     510(k) NO: K110943(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE RP-2138     SE DECISION MADE: 22-JUL-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APNEA GUARD
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K111110(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 22-JUL-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUS CERVICAL SPINAL FIXATION SYSTEM
L&K BIOMED CO.,LTD.               510(k) NO: K103414(TRADITIONAL)
ATTN: SUN  YI LEE                 PHONE NO : 822 262 41471
#1104 ACE HIGH-END TOWER 3 CHA 371SE DECISION MADE: 22-JUL-11
SEOUL    KS 153-803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTOGRAPH EVO 3D
VILLA SISTEMI MEDICALI S.P.A.     510(k) NO: K111152(ABBREVIATED)
ATTN: PAOLO  CASAGRANDE SANTIN    PHONE NO : 390 248 8591
VIA DELLE AZALEE 3                SE DECISION MADE: 22-JUL-11
BUCCINASCO    IT 20090            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERVICAL CAGE
EISERTECH, LLC                    510(k) NO: K110915(ABBREVIATED)
ATTN: LUKAS  EISERMANN            PHONE NO : 888 262 2817   
2555 FRONT STREET                 SE DECISION MADE: 22-JUL-11
SAN DIEGO CA 92103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIM E30 II CO2 LASER
LASERING S.R.L.                   510(k) NO: K110984(SPECIAL)
ATTN: ALLEN R HOWES               PHONE NO : 925 355 0750   
2246 CAMINO RAMON                 SE DECISION MADE: 22-JUL-11
SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIAC TRIGGER MONITOR
IVY BIOMEDICAL SYSTEMS, INC.      510(k) NO: K110987(SPECIAL)
ATTN: DICK  LISTRO                PHONE NO : 203 481 4183   
11 BUSINESS PARK DR.              SE DECISION MADE: 22-JUL-11
BRANFORD CT 06405                 510(k) STATEMENT

DEVICE: MYLABSEVEN, MYLABALPHA
ESAOTE, S.P.A.                    510(k) NO: K111302(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N MERIDIAN ST., STE 150     SE DECISION MADE: 22-JUL-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUFF SENTRY
VENTLAB CORP.                     510(k) NO: K102674(TRADITIONAL)
ATTN: JAMES  COCHIE               PHONE NO : 336 753 5000   
155 BOYCE DRIVE                   SE DECISION MADE: 22-JUL-11
MOCKSVILLE NC 27028               510(k) STATEMENT

DEVICE: RE / STASIS (TM) GINGIVAL RETRACTION PASTE
CENTRIX, INC.                     510(k) NO: K111348(TRADITIONAL)
ATTN: JOHN  DISCKO                PHONE NO : 203 567 7426   
770 RIVER RD.                     SE DECISION MADE: 22-JUL-11
SHELTON CT 06484 5458             510(k) STATEMENT

DEVICE: MP 719
MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K111524(TRADITIONAL)
ATTN: SERGIO  FINKIELSZTEIN       PHONE NO : 781 270 3200   
107 WATER ST.                     SE DECISION MADE: 22-JUL-11
DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K111631(TRADITIONAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 22-JUL-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K111866(SPECIAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 22-JUL-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
GOLD STANDARD ORTHOPEDICS LLC     510(k) NO: K110990(TRADITIONAL)
ATTN: JAMES  RITTER               PHONE NO : 574 527 3256   
3415 N. OLD FARM RD. E.           SE DECISION MADE: 25-JUL-11
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISION ONE LASER SYSTEM
LUMENIS INC.                      510(k) NO: K111213(SPECIAL)
ATTN: JACE R MCLANE               PHONE NO : 801 656 2329   
3959 WEST 1820 SOUTH              SE DECISION MADE: 25-JUL-11
SALT LAKE CITY UT 84104           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CXI TRIFORCE
COOK INCORPORATED                 510(k) NO: K111263(TRADITIONAL)
ATTN: MOLLY  BUSENBARK            PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 25-JUL-11
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIXTAL DZ-4100 SERIES PULSE OXIMETER
DIXTAL MEDICAL, INC.              510(k) NO: K103285(SPECIAL)
ATTN: ROBERT H SCHIFFMAN          PHONE NO : 203 269 1112   
101 N. Plains Industrial Rd.      SE DECISION MADE: 25-JUL-11
Wallingford CT 06492              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRCUMAURAL ADHESIVE REPLACEMENT
R & D MEDICAL PRODUCTS, INC.      510(k) NO: K111555(TRADITIONAL)
ATTN: JAMES  PERRAULT             PHONE NO : 949 472 9346   
20492 CRESCENT BAY DR. #106       SE DECISION MADE: 25-JUL-11
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3.7MM/5.0MM DYNAMIC LOCKING SCREW
SYNTHES USA                       510(k) NO: K110592(TRADITIONAL)
ATTN: CHRISTOPHER  HACK, ESQ      PHONE NO : 610 719 6940   
1301 GOSHEN PKWY                  SE DECISION MADE: 25-JUL-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYBRID PICA WHOLE-BODY MRI SYSTEM
TIME MEDICAL LIMITED              510(k) NO: K110942(ABBREVIATED)
ATTN: JOHN  BABY                  PHONE NO : 852 215 61711
NO. 2 SCIENCE PARK WEST AVE. SHATISE DECISION MADE: 26-JUL-11
HONG KONG    CH CH                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX SPINE SYSTEM
SPINECRAFT LLC                    510(k) NO: K110906(TRADITIONAL)
ATTN: AMI  AKALLAL-ASAAD          PHONE NO : 708 531 9700   
2215 ENTERPRISE DRIVE SUITE 1504  SE DECISION MADE: 26-JUL-11
WESTCHESTER IL 60154              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATCH, PLEDGET AND INTRACARDIAC
CORMATRIX CARDIOVASCULAR, INC.    510(k) NO: K111187(TRADITIONAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   
155 MOFFETT PARK DRIVE SUITE 210  SE DECISION MADE: 26-JUL-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRATED INNOVA - S5I SYSTEM OPTION
GE HEALTHCARE                     510(k) NO: K111209(TRADITIONAL)
ATTN: FAYCAL  KHERRA              PHONE NO : 330 130 704082
283, RUE DE LA MINIERE            SE DECISION MADE: 26-JUL-11
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCIS ACTIVON TUBE
CALIDAD SOLUTIONS, INC.           510(k) NO: K101114(TRADITIONAL)
ATTN: JOHN  BILLINGS              PHONE NO : 206 575 7762   
22433 72 AVENUE S                 SE DECISION MADE: 26-JUL-11
KENT WA 98032                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ S8
GE HEALTHCARE                     510(k) NO: K111582(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE MAIL STOP RPSE DECISION MADE: 26-JUL-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
CARDIOVASCULAR SYSTEMS, INC.      510(k) NO: K111388(TRADITIONAL)
ATTN: MEGAN M BRANDT              PHONE NO : 651 259 2805   
651 CAMPUS DR.                    SE DECISION MADE: 26-JUL-11
ST. PAUL MN 55112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TISSUE SAMPLING NEEDLE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103694(TRADITIONAL)
ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 27-JUL-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD AUTOSHIELD DUO PEN NEEDLE
BECTON, DICKINSON AND COMPANY     510(k) NO: K110703(TRADITIONAL)
ATTN: CYNTHIA  LACATENA           PHONE NO : 201 847 6869   
1 BECTON DRIVE MC 372             SE DECISION MADE: 27-JUL-11
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K110156(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 27-JUL-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
DERMA SCIENCES, INC.              510(k) NO: K110546(TRADITIONAL)
ATTN: RONALD S WARREN             PHONE NO : 858 753 1961   
11440 W. BERNARDO COURT, SUITE 300SE DECISION MADE: 27-JUL-11
SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHANDONG JIANHONG NEW MATERIAL COM510(k) NO: K111752(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG, 1 JIAN XIANG YUAN SE DECISION MADE: 27-JUL-11
HUAN ZHONG RD, BEIJING    CH 10083510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
NIDEK CO., LTD.                   510(k) NO: K111493(TRADITIONAL)
ATTN: MICHAEL J BILLIG            PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE SUITE 100  SE DECISION MADE: 27-JUL-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
MEDTRONIC INC.                    510(k) NO: K111972(SPECIAL)
ATTN: JESSICA  SIXBERRY           PHONE NO : 763 514 8949   
7611 NORTHLAND DRIVE              SE DECISION MADE: 27-JUL-11
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
PHARMAJET, INC.                   510(k) NO: K111517(SPECIAL)
ATTN: MICHAEL J RYAN              PHONE NO : 303 526 4278   
400 CORORATE CIRCLE, SUITE N      SE DECISION MADE: 27-JUL-11
GOLDEN CO 80401                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
TELCARE, INC.                     510(k) NO: K110571(TRADITIONAL)
ATTN: JONATHAN C JAVITT           PHONE NO : 240 396 6003   
3 BETHESDA METRO CENTER SUITE 430 SE DECISION MADE: 28-JUL-11
BETHESDA MD 20814                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
MASIMO CORPORATION                510(k) NO: K110723(SPECIAL)
ATTN: SHELLY  HARRIS              PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 28-JUL-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREGNANCY ONE STEP RAPID TEST
LEHNUS & ASSOCIATES CONSULTING    510(k) NO: K103574(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570 620 0198   
150 CHERRY LANE RD.               SE DECISION MADE: 28-JUL-11
EAST STROUDSBURG PA 18301 8804    510(k) STATEMENT

DEVICE: SMR SHOULDER SYSTEM- REVISION STEMS
LIMACORPORATE S.P.A.              510(k) NO: K111212(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 28-JUL-11
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
PARCUS MEDICAL, LLC               510(k) NO: K111000(TRADITIONAL)
ATTN: BARTON  BRACY               PHONE NO : 920 746 2972   
839 SOUTH NEENAH AVE.             SE DECISION MADE: 28-JUL-11
STURGEON BAY WI 54235             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
WET NOSE TECHNOLOGIES, LLC        510(k) NO: K111191(SPECIAL)
ATTN: LIONEL  NEWMAN              PHONE NO : 323 733 0406   
3750 2ND AVE                      SE DECISION MADE: 28-JUL-11
LOS ANGELES CA 90018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRI-Q SYSTEM
RESONANCE HEALTH ANALYSIS SERVICES510(k) NO: K111222(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949 262 0411   
3722 AVE. SAUSALITO               SE DECISION MADE: 28-JUL-11
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES STERNAL ZIPFIX SYSTEM
SYNTHES (USA)                     510(k) NO: K110789(TRADITIONAL)
ATTN: ANDREA M TASKER             PHONE NO : 610 719 6290   
1301 GOSHEN PARKWYA               SE DECISION MADE: 28-JUL-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
SOFLEX LIMITED                    510(k) NO: K110261(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 28-JUL-11
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: XELIS 3D
INFINITT CO., LTD.                510(k) NO: K103130(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 940 300 8601   
1600 MANCHESTER WAY               SE DECISION MADE: 28-JUL-11
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: N-FORCE FIXATION SYSTEM
INNOVISION, INC.                  510(k) NO: K102528(TRADITIONAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 28-JUL-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
EXACTECH, INC.                    510(k) NO: K111400(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 28-JUL-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENNER TRACHEAL SEAL MONITOR
VENNER MEDICAL (SINGAPORE) PTE LTD510(k) NO: K110631(TRADITIONAL)
ATTN: HCHRISTINE  BRAUER, PH.D.   PHONE NO : 301 545 1990   
7 TRAIL HOUSE COURT               SE DECISION MADE: 28-JUL-11
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPSY VALVE
ENDOCHOICE, INC.                  510(k) NO: K111821(TRADITIONAL)
ATTN: THERON  GOBER               PHONE NO : 678 534 6021   
11810 WILLS ROAD SUITE 100        SE DECISION MADE: 28-JUL-11
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNAP (R) WOUND CARE SYSTEM
SPIRACUR, INC.                    510(k) NO: K111393(SPECIAL)
ATTN: SARAH  CANIO                PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE SUITE 100  SE DECISION MADE: 28-JUL-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITREAVIEW SOFTWARE 6.1
VITAL IMAGES, INC.                510(k) NO: K111892(TRADITIONAL)
ATTN: IAN  NEMEROV                PHONE NO : 952 487 9622   
5850 OPUS PARKWAY, SUITE 300      SE DECISION MADE: 28-JUL-11
MINNETONKA MN 55343 4414          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INTELLISPACE PACS 4.X
PHILIPS HEALTHCARE INFORMATICS, IN510(k) NO: K111804(TRADITIONAL)
ATTN: VICTORIA S MACKINNON        PHONE NO : 650 293 2373   
4100 EAST THIRD AVE, STE 101      SE DECISION MADE: 28-JUL-11
FOSTER CITY CA 94404              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
STRYKER SPINE                     510(k) NO: K110419(TRADITIONAL)
ATTN: TIFFANI D ROGERS            PHONE NO : 201 760 8206   
2 PEARL COURT                     SE DECISION MADE: 28-JUL-11
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
COLLAGEN MATRIX, INC.             510(k) NO: K110600(TRADITIONAL)
ATTN: PEGGY  HANSEN               PHONE NO : 201 405 1477   
15 THORNTON ROAD                  SE DECISION MADE: 29-JUL-11
OAKLAND NJ 07436                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
SPECTRA MEDICAL DEVICES, INC.     510(k) NO: K103740(TRADITIONAL)
ATTN: DAVID L ROSEN, B.S. PHARM., PHONE NO : 202 672 5430   
3000 K ST., NW                    SE DECISION MADE: 29-JUL-11
WASHINGTON DC 20007               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PE-210AK SWITCH BOX
NIHON KOHDEN CORP.                510(k) NO: K110376(TRADITIONAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 29-JUL-11
FOOTHILL CA 92610                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
HANDELSHAUS DITTMAN GMBH          510(k) NO: K110390(TRADITIONAL)
ATTN: KANG  JIANG PING            PHONE NO : 867 552 7652471
NO.3 BUILDING,XILIYIANGGUANG INDUSSE DECISION MADE: 29-JUL-11
SHENZHEN    CH 518108             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAIN BUDDY
BIOMEDICAL LIFE SYSTEMS, INC.     510(k) NO: K102051(TRADITIONAL)
ATTN: GARY  BUSSETT               PHONE NO : 760 727 5600   
P.O. BOX 1360                     SE DECISION MADE: 29-JUL-11
VISTA CA 92085 1360               510(k) STATEMENT

DEVICE: JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
JIANGSU SHENLI MEDICAL PRODUCTION 510(k) NO: K103830(ABBREVIATED)
ATTN: DARREN  REEVES              PHONE NO : 804 307 7706   
15637 FOX COVE CIRCLE             SE DECISION MADE: 29-JUL-11
MOSELY VA 23120                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA CUSTOMIZED ABUTMENT
BIODENTA SWISS AG                 510(k) NO: K110778(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934
TRAMSTRASSE 16                    SE DECISION MADE: 29-JUL-11
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTNAVIGATOR RELEASE 1
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K111245(ABBREVIATED)
ATTN: LYNN  HARMER                PHONE NO : 425 487 7312   
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 29-JUL-11
BOTHELL WA 98021 8431             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSI O-BALL ABUTMENT HEAD IMPLANTS
JUELL DENTAL                      510(k) NO: K110548(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
2401 N COMMERCE                   SE DECISION MADE: 29-JUL-11
ARDMORE OK 73401                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K111611(SPECIAL)
ATTN: JOHN C KNORPP               PHONE NO : 801 208 4389   
1600 WEST MERIT PKWY.             SE DECISION MADE: 29-JUL-11
SOUTH JORDAN UT 84095 2415        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLIDECROSS SUPPORT CATHETER
TERUMO MEDICAL CORP.              510(k) NO: K111556(TRADITIONAL)
ATTN: MARK  UNTERREINER           PHONE NO : 410 392 7213   
950 ELKTON BLVD.                  SE DECISION MADE: 29-JUL-11
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOYAGER PERITONEAL DIALYSIS SYSTEM
DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K103220(TRADITIONAL)
ATTN: ROGER A LEROUX              PHONE NO : 603 669 5139   
340 COMMERCIAL ST.                SE DECISION MADE: 29-JUL-11
MANCHESTER NH 03101               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO WARMING CABINET
STERIS CORPORATION                510(k) NO: K111870(SPECIAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 29-JUL-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
NAVILYST MEDICAL, INC.            510(k) NO: K111906(SPECIAL)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 658 7945   
26 FOREST STREET                  SE DECISION MADE: 29-JUL-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
LEMAITRE VASCULAR, INC.           510(k) NO: K111884(SPECIAL)
ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 29-JUL-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
MEDPRO SAFETY PRODUCTS, INC.      510(k) NO: K111424(SPECIAL)
ATTN: JUDI  SMITH                 PHONE NO : 410 592 2060   
P.O. BOX 103                      SE DECISION MADE: 29-JUL-11
BALDWIN MD 21013                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
INSERT MOLDING SOLUTIONS, INC     510(k) NO: K111529(TRADITIONAL)
ATTN: PAUL  HENDRIXSON            PHONE NO : 678 965 5334   
4325 SETTINGDOWN CIRCLE SUITE 103 SE DECISION MADE: 29-JUL-11
CUMMING GA 30028                  510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   226                                     
                                                 TOTAL WITH SUMMARIES        212                                     
                                                 TOTAL WITH STATEMENTS        14