SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUL-2006 THROUGH 31-JUL-2006
DEVICE: BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,
AARON MEDICAL INDUSTRIES 510(k) NO: K061307(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727-803-8513
7100 30TH AVE. NORTH SE DECISION MADE: 18-JUL-06
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN RUBY SYSTEM
ABBOTT LABORATORIES 510(k) NO: K061667(SPECIAL)
ATTN: MICHELLE ROEDING PHONE NO : 408-567-3781
5440 PATRICK HENRY DR. SE DECISION MADE: 10-JUL-06
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARCLOSE INTRODUCER SET MODEL- 1002
ABBOTT VASCULAR INC. 510(k) NO: K060902(SPECIAL)
ATTN: KIM SMITH -SERVANCE PHONE NO : 650-474-3383
400 SAGINAW SE DECISION MADE: 07-JUL-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
ACCELERATED CARE PLUS CORP. 510(k) NO: K060191(TRADITIONAL)
ATTN: PATRICK PARKER PHONE NO : 800-350-1100
9855 DOUBLE R BLVD. #100 SE DECISION MADE: 12-JUL-06
RENO, NV 89521 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: FLEXO DENTAL RESIN MATERIAL
ACI, INC. 510(k) NO: K061501(TRADITIONAL)
ATTN: CHARLES LEE PHONE NO : 913-220-2045
5830 WOODSON SE DECISION MADE: 26-JUL-06
STE: 3 510(k) SUMMARY AVAILABLE FROM FDA
MISSION, KS 66202
DEVICE: ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001
ACRO BIOTECH LLC. 510(k) NO: K060354(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-332-4651
9500 7TH STREET UNIT M SE DECISION MADE: 28-JUL-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: NEOZOLINE VENTILATION TUBES
ADEPT MEDICAL LTD 510(k) NO: K061058(TRADITIONAL)
ATTN: JASON MARSH PHONE NO : 098 152 999
2 MCDONALD STREET, MORNINGSIDE SE DECISION MADE: 12-JUL-06
AUCKLAND, NEW ZEALAND 1003 510(k) STATEMENT
DEVICE: POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POL
ADVANCED INFUSION, INC. 510(k) NO: K061356(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 480-768-9747
920 EAST UNIVERSITY DR. SE DECISION MADE: 03-JUL-06
SUITE D202 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281
DEVICE: MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
AESCULAP 510(k) NO: K061135(TRADITIONAL)
ATTN: LISA WEIKERT PHONE NO : 215-256-4201
1499 DELP DRIVE SE DECISION MADE: 11-JUL-06
HARLYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELSITE/ CELSITE CONCEPT, ACCESS PORTS
AESCULAP, INC. 510(k) NO: K061424(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 31-JUL-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILENE MESH
AESCULAP, INC. 510(k) NO: K061704(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9274
3773 CORPORATE PKWY. SE DECISION MADE: 19-JUL-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAP-T
AIRWAY MANAGEMENT INC. 510(k) NO: K061732(SPECIAL)
ATTN: DARREN HENDERSON PHONE NO : 214-369-0978
6116 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 12-JUL-06
SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75206
DEVICE: VERIFY DRY HEAT LABEL
ALBERT BROWNE LTD. 510(k) NO: K053479(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 18-JUL-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URIN
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K060527(ABBREVIATED)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
13200 GREGG ST. SE DECISION MADE: 25-JUL-06
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35X
ALPHATEC SPINE, INC. 510(k) NO: K061321(SPECIAL)
ATTN: PAULA MORGAN PHONE NO : 760-431-9286
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 07-JUL-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: ALTES BUTTRESS PLATING SYSTEM
ALTIVA CORP. 510(k) NO: K061482(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704-409-1754
9800 SOUTHERN PINES BLVD. SE DECISION MADE: 26-JUL-06
SUITE I 510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28273
DEVICE: AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODE
AMEDICA BIOTECH, INC. 510(k) NO: K061556(SPECIAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 21-JUL-06
HAYWARD, CA 94545 510(k) STATEMENT
DEVICE: ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
ANULEX TECHNOLOGIES, INC 510(k) NO: K061386(TRADITIONAL)
ATTN: TIM MILLER PHONE NO : 952-224-4003
5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 05-JUL-06
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURPASS
APEX DENTAL MATERIALS, INC. 510(k) NO: K061981(ABBREVIATED)
ATTN: CHRIS KULTON PHONE NO : 877-273-9123
23329 MALLARD COURT SE DECISION MADE: 31-JUL-06
DEER PARK, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
APPLIED SPINE TECHNOLOGIES 510(k) NO: K061162(TRADITIONAL)
ATTN: MICHELE LUCEY PHONE NO : 203-503-0280
300 GEORGE ST. SE DECISION MADE: 26-JUL-06
SUITE 511 510(k) SUMMARY AVAILABLE FROM FDA
NEW HAVEN, CT 06511
DEVICE: ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
ARTHREX, INC. 510(k) NO: K061665(SPECIAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 25-JUL-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
ARTHROCARE CORP. 510(k) NO: K060425(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426
680 VAQUEROS AVE. SE DECISION MADE: 12-JUL-06
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
ARTHROCARE CORP. 510(k) NO: K061349(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-276-4306
27130 A PASEO ESPADA SE DECISION MADE: 14-JUL-06
SUITE 1427 510(k) SUMMARY AVAILABLE FROM FDA
SAN JUAN CAPISTRANO, CA 92675
DEVICE: ALLTHREAD LACTOSORB SUTURE ANCHOR
ARTHROTEK, INC. 510(k) NO: K061389(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
P.O. BOX 587 SE DECISION MADE: 19-JUL-06
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITCH LACTOSORB SUTURE ANCHOR
ARTHROTEK, INC. 510(k) NO: K061657(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
56 EAST BELL DR. SE DECISION MADE: 25-JUL-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: FITPACK
ASP PLASTICS PTY LTD. 510(k) NO: K060037(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
2700 LA PAZ ROAD, SUITE 314 SE DECISION MADE: 25-JUL-06
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
ATLANTIS COMPONENTS, INC. 510(k) NO: K053654(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 31-JUL-06
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2
ATRICURE, INC. 510(k) NO: K061593(TRADITIONAL)
ATTN: ELSA C ABRUZZO PHONE NO : 513-755-4100
6033 SCHUMACHER PARK DR. SE DECISION MADE: 12-JUL-06
WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QL LOCKING SYRINGE
ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K060643(TRADITIONAL)
ATTN: DAN CLARK PHONE NO : 256-317-2220
1426 CURT FRANCIS RD. SE DECISION MADE: 12-JUL-06
ARAB, AL 35016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXYALOOP NONABSORBABLE BONE ANCHOR
AXYA MEDICAL, INC. 510(k) NO: K060970(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 978-232-9997
100 CUMMINGS CENTER SE DECISION MADE: 05-JUL-06
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLO
BARRIERMED GLOVE CO. 510(k) NO: K053406(TRADITIONAL)
ATTN: VICTOR J RAGUCCI PHONE NO : 407-771-4424
155 TECHNOLOGY PARK SE DECISION MADE: 05-JUL-06
LAKE MARY, FL 32746 510(k) STATEMENT
DEVICE: ADVIA IMS CPSA CONTROL
BAYER HEALTHCARE, LLC 510(k) NO: K061137(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 06-JUL-06
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
BAYER HEALTHCARE, LLC 510(k) NO: K061139(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 06-JUL-06
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS
BECKMAN COULTER, INC. 510(k) NO: K061382(TRADITIONAL)
ATTN: VALYNDA L MACHEN PHONE NO : 952-368-1383
1000 LAKE HAZELTINE DR. SE DECISION MADE: 06-JUL-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
BECKMAN COULTER, INC. 510(k) NO: K061574(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 21-JUL-06
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE
BECTON, DICKINSON & CO. 510(k) NO: K061327(TRADITIONAL)
ATTN: VICKI L KENNEDY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 03-JUL-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE
BECTON, DICKINSON & CO. 510(k) NO: K061673(TRADITIONAL)
ATTN: VICKI L KENNEDY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 28-JUL-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOA
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K053213(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500
901 GRAYSON ST., SUITE 101 SE DECISION MADE: 06-JUL-06
BERKELEY, CA 94710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTHSHAPES
BIOCELLULASE, INC. 510(k) NO: K061603(TRADITIONAL)
ATTN: ROBERT NAGEL PHONE NO : 508-650-4808
ONE APPLE HILL DRIVE SE DECISION MADE: 03-JUL-06
SUITE 316 510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760
DEVICE: OCULASE MD
BIOLASE TECHNOLOGY, INC. 510(k) NO: K052354(TRADITIONAL)
ATTN: JEFFREY W JONES PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 05-JUL-06
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLUCENT APPLICATOR, MODEL RTA-XX
BIOLUCENT, INC. 510(k) NO: K061241(TRADITIONAL)
ATTN: J. DAVID CAMPBELL PHONE NO : 949-349-1380
6 JOURNEY, SUITE 325 SE DECISION MADE: 28-JUL-06
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K061476(TRADITIONAL)
ATTN: GARY BUSSETT PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 26-JUL-06
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
BIOMET MANUFACTURING CORP. 510(k) NO: K061423(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 27-JUL-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: HYDROMARK BIOPSY SITE MARKER
BIOPSY SCIENCES, LLC 510(k) NO: K060769(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON RD. SE DECISION MADE: 25-JUL-06
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVAPIN
BIORETEC LTD 510(k) NO: K061164(TRADITIONAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 207 789500
HERMIAKATU 22 MODULIGHT BLDG SE DECISION MADE: 06-JUL-06
TAMERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 M
BIOSITE INCORPORATED 510(k) NO: K060788(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 888-246-7483
9975 SUMMERS RIDGE RD SE DECISION MADE: 10-JUL-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTRONIK ENDOCARDIAL PACING LEADS
BIOTRONIK, INC. 510(k) NO: K061212(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 10-JUL-06
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIN SCREW
BK MEDITECH CO., LTD. 510(k) NO: K061599(TRADITIONAL)
ATTN: BYUNGJUN PARK PHONE NO : 82 31 3529135
215-5 YODANG-LI, YANGGAM-MYUN SE DECISION MADE: 26-JUL-06
HWASUNG-SI, KYUNGGI-DO, REPUBLIC O510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K061229(TRADITIONAL)
ATTN: MARTIN SPRUNCK PHONE NO : 973-406-2847
1211 HAMBURG TURNPIKE SE DECISION MADE: 24-JUL-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
BOB J. JOHNSON & ASSOCIATES 510(k) NO: K060942(TRADITIONAL)
ATTN: JON HULSEY PHONE NO : 281-873-5555
16420 W. HARDY RD., STE. 100 SE DECISION MADE: 07-JUL-06
HOUSTON, TX 77060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOEHRINGER LABORATORIES, INC., SUCTION PUMP SYSTEM 8600 SERIES
BOEHRINGER LABORATORIES 510(k) NO: K061788(TRADITIONAL)
ATTN: CHRISTOPHER RADL PHONE NO : 610-278-0900
500 E. WASHINGTON ST. SE DECISION MADE: 11-JUL-06
NORRISTOWN, PA 19401 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLEXVIEW SYSTEM
BOSTON SCIENTIFIC 510(k) NO: K062050(TRADITIONAL)
ATTN: CHRISTINA L ROWE PHONE NO : 408-845-1813
3200 LAKESIDE DRIVE SE DECISION MADE: 31-JUL-06
SANTA CLARA, CA 95033 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IPLAN RT DOSE
BRAINLAB AG 510(k) NO: K053584(SPECIAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 12-JUL-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K061514(TRADITIONAL)
ATTN: TERRENCE O'BRIEN PHONE NO : 262-953-5315
1780 EXECUTIVE DR. SE DECISION MADE: 13-JUL-06
OCONOMOWOC, WI 53066 510(k) STATEMENT
DEVICE: I-STYLE BONE MARROW ASPIRATION NEEDLE
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K061570(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
75 ARKAY DRIVE SE DECISION MADE: 03-JUL-06
P.O. BOX 11067 510(k) SUMMARY AVAILABLE FROM FDA
HAUPPAUGE, NY 11788
DEVICE: POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER
C.R. BARD, INC. 510(k) NO: K060812(TRADITIONAL)
ATTN: SUSAN SCOTT PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 14-JUL-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALYPSO 4D LOCALIZATION SYSTEM
CALYPSO MEDICAL TECHNOLOGIES INC 510(k) NO: K060906(TRADITIONAL)
ATTN: ERIC MEIER PHONE NO : 206-774-4205
2101 FOURTH AVE STE 1550 SE DECISION MADE: 28-JUL-06
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENLASER 800 PLUS
CAO GROUP, INC. 510(k) NO: K061366(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
8683 SOUTH 700 WEST SE DECISION MADE: 10-JUL-06
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K061285(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 26-JUL-06
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMULATE, COLOR CHANGE ALGINATE
CAVEX HOLLAND B.V. 510(k) NO: K061267(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 312 35307763
PO BOX 852 SE DECISION MADE: 10-JUL-06
HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT
DEVICE: XPERT, GENEXPERT DX SYSTEM
CEPHEID 510(k) NO: K060540(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 240-400-8230
904 CARIBBEAN DRIVE SE DECISION MADE: 25-JUL-06
SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN NERVE WRAP
COLLAGEN MATRIX, INC. 510(k) NO: K060952(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 14-JUL-06
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAWOUND DRESSING
COLLAMATRIX CO., INC. 510(k) NO: K061474(TRADITIONAL)
ATTN: DENNIS J N. SEAH PHONE NO : 886 277 209988
2ND FLOOR, NO. 360, RUIGUANG SE DECISION MADE: 05-JUL-06
RD NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: OASIS WOUND MATRIX
COOK BIOTECH, INC. 510(k) NO: K061711(SPECIAL)
ATTN: PERRY W GUINN PHONE NO : 765-807-1942
1425 INNOVATION PLACE SE DECISION MADE: 19-JUL-06
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH "VARIA" ND:YAG LASER SYSTEM
COOLTOUCH, INC. 510(k) NO: K060966(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BLVD. SE DECISION MADE: 31-JUL-06
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
DADE BEHRING, INC. 510(k) NO: K060489(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 21-JUL-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
DADE BEHRING, INC. 510(k) NO: K061338(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 06-JUL-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
DADE BEHRING, INC. 510(k) NO: K061390(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
500 GBC DR, MAILSTOP 514 SE DECISION MADE: 05-JUL-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K061536(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 18-JUL-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA FLEX REAGENT CARTRIDGES
DADE BEHRING, INC. 510(k) NO: K061655(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 10-JUL-06
BLDG.500 M.S. 514; PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K061687(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 21-JUL-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC34
DADE BEHRING, INC. 510(k) NO: K061702(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 10-JUL-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
DADE BEHRING, INC. 510(k) NO: K061751(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 13-JUL-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP),
DADE BEHRING, INC. 510(k) NO: K061792(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 18-JUL-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL
DADE BEHRING, INC. 510(k) NO: K061818(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 18-JUL-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINA
DADE BEHRING, INC. 510(k) NO: K062024(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 28-JUL-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTIUM PROSTHETICS
DENTIUM CO., LTD. 510(k) NO: K052957(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 27-JUL-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE WAX REMOVER
DENTSPLY INTERNATIONAL 510(k) NO: K061580(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR. WEST SE DECISION MADE: 28-JUL-06
221 W. PHILADELPHIA ST., #60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY AML HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K061833(SPECIAL)
ATTN: ANNE SCHULER PHONE NO : 574-372-7098
700 ORTHOPAEDIC DR. SE DECISION MADE: 17-JUL-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSOFT HARP
DIAGNOSOFT, INC. 510(k) NO: K061368(TRADITIONAL)
ATTN: AMR A AWADALLAH PHONE NO : 650-320-9397
3461 KENNETH DRIVE SE DECISION MADE: 28-JUL-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODIGY
DIAGNOSTIC DEVICES INC. 510(k) NO: K053593(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 06-JUL-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODIGY BLOOD GLUCOSE TEST SYSTEM
DIAGNOSTIC DEVICES, INC. 510(k) NO: K060467(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 13-JUL-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE RENIN IRMA
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K061758(SPECIAL)
ATTN: SCOTT BISHOP PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD. SE DECISION MADE: 28-JUL-06
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA - CONTROL LA 1+2
DIAGNOSTICA STAGO, INC. 510(k) NO: K061803(TRADITIONAL)
ATTN: LAURA WORFOLK PHONE NO : 973-631-1200
5 CENTURY DR. SE DECISION MADE: 28-JUL-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASORIN LIAISON TREPONEMA ASSAY
DIASORIN, INC. 510(k) NO: K061247(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850
1951 NORTHWESTERN AVE. SE DECISION MADE: 31-JUL-06
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
DIAZYME LABORATORIES 510(k) NO: K060619(TRADITIONAL)
ATTN: ROLAND STRICKLAND PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT. SE DECISION MADE: 21-JUL-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGIS1;MAGIS2
DIREX SYSTEMS CORP. 510(k) NO: K061713(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837
437 TURNPIKE ST. SE DECISION MADE: 21-JUL-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MASIMO SET SP02 POD
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K061329(SPECIAL)
ATTN: THOMAS MCINTOSH PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 07-JUL-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
EBI, L.P. 510(k) NO: K061441(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 25-JUL-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEL SOL BLUE LIGHT THERAPY SYSTEM
EDGE SYSTEMS CORPORATION 510(k) NO: K061470(TRADITIONAL)
ATTN: GARY S MOCNIK PHONE NO : 949-433-0413
24372 MCCLOUD COURT SE DECISION MADE: 20-JUL-06
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: LEKSELL GAMMAPLAN
ELEKTA INSTRUMENT AB 510(k) NO: K061540(SPECIAL)
ATTN: LOUISE LINGBLAD PHONE NO : 468 587 25400
KUNGSTENSGATAN 18 SE DECISION MADE: 05-JUL-06
P.O.BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN S-103 93
DEVICE: ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
ENVITEC-WISMAR GMBH 510(k) NO: K060675(SPECIAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER RD SE DECISION MADE: 17-JUL-06
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERAD PACS
ERAD, INC. 510(k) NO: K061421(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 25-JUL-06
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPE
ESAOTE, S.P.A. 510(k) NO: K061429(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 25-JUL-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC
ETHICON ENDO-SURGERY, INC. 510(k) NO: K061156(TRADITIONAL)
ATTN: TOM MORRIS PHONE NO : 513-337-3235
4545 CREEK RD. SE DECISION MADE: 03-JUL-06
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDS PLUS ANTIBACTERIAL SUTURE
ETHICON, INC. 510(k) NO: K061037(TRADITIONAL)
ATTN: BYRAN A LISA PHONE NO : 908-218-3392
ROUTE 22 WEST SE DECISION MADE: 14-JUL-06
P.O.BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100
ETHICON, INC. 510(k) NO: K061050(TRADITIONAL)
ATTN: BRYAN LISA PHONE NO : 908-218-3392
P.O. BOX 151 SE DECISION MADE: 14-JUL-06
ROUTE 22 WEST 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: SURGI-CUF REUSABLE, RS SERIES
ETHOX INTERNATIONAL 510(k) NO: K061962(TRADITIONAL)
ATTN: JOHN RIGGI PHONE NO : 716-842-4000
251 SENECA ST. SE DECISION MADE: 25-JUL-06
BUFFALO, NY 14204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREE
EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060785(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 07-JUL-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNUG PLUG PUNCTUM PLUG
FCI OPHTHALMICS, INC. 510(k) NO: K061398(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
344 ANNABELLE POINT RD. SE DECISION MADE: 11-JUL-06
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: FEMECC ENDOCERVICAL CURETTE
FEMSPEC L.L.C. 510(k) NO: K060320(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 360-379-3660
1530 HOLCOMB STREET SE DECISION MADE: 28-JUL-06
PORT TOWNSEND, WA 98368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
FISHER DIAGNOSTICS 510(k) NO: K052407(TRADITIONAL)
ATTN: M. HEATHER CAMERON PHONE NO : 540-869-8163
8365 VALLEY PIKE SE DECISION MADE: 18-JUL-06
MIDDLETOWN, VA 22645-0307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
FONAR CORP. 510(k) NO: K061930(SPECIAL)
ATTN: LUCIANO BONANNI PHONE NO : 631-694-2929
110 MARCUS DR. SE DECISION MADE: 28-JUL-06
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORYOU POWERED WHEELCHAIR, MODEL FC-100
FORYOU TECHNOLOGY CO., LTD. 510(k) NO: K061693(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 06-JUL-06
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) STATEMENT
DEVICE: EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FRONTLINE MEDICAL 510(k) NO: K060289(TRADITIONAL)
ATTN: PAUL SLATTERY PHONE NO : 011 353 874184183
INNOVATION WORKS SE DECISION MADE: 07-JUL-06
NATIONAL TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: FSSB NYLON SURGICAL SUTURES
FSSB CHIRURGISCHE NADELN GMBH 510(k) NO: K060471(ABBREVIATED)
ATTN: CHERITA JAMES PHONE NO : 202-546-1262
719 A STREET, NE. SE DECISION MADE: 26-JUL-06
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC XLC-100 CAPSULE
GC AMERICA, INC. 510(k) NO: K061535(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 14-JUL-06
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: LIGHTSPEED 7.1 CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K061817(TRADITIONAL)
ATTN: LEKSHMI NAIR PHONE NO : 262-312-7415
3000 N GRANDVIEW BLVD. SE DECISION MADE: 12-JUL-06
W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
GEN-PROBE, INC. 510(k) NO: K053446(TRADITIONAL)
ATTN: BRIAN J SHEA PHONE NO : 858-410-8891
10210 GENETIC CENTER DR. SE DECISION MADE: 25-JUL-06
SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID - I
GENERAL ELECTRIC CO. 510(k) NO: K061525(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
P.O. BOX 414 SE DECISION MADE: 03-JUL-06
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VOLUSON E8 ULTRASOUND SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K061682(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 12-JUL-06
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERE STABILIZATION SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K061202(SPECIAL)
ATTN: KELLY BAKER PHONE NO : 610-415-9000
303 SCHELL LN. SE DECISION MADE: 20-JUL-06
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS VNG/ENG TYPE 1068
GN OTOMETRICS A/S 510(k) NO: K061791(TRADITIONAL)
ATTN: MICHAEL HAMACHER PHONE NO : 800-289-2150
125 COMMERCE DRIVE SE DECISION MADE: 11-JUL-06
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K061562(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 11-JUL-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
GUIDANT CORP. 510(k) NO: K061865(SPECIAL)
ATTN: CHRISTINA L LOWE PHONE NO : 408-845-1813
3200 LAKESIDE DR. SE DECISION MADE: 27-JUL-06
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALILEO GOLD ASV
HAMILTON MEDICAL AG 510(k) NO: K061090(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 418 166 06479
VIA CRUSCH 8 SE DECISION MADE: 17-JUL-06
BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAGMENT PLATE SYSTEM
HAND INNOVATIONS, LLC. 510(k) NO: K061748(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 17-JUL-06
PO BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581
DEVICE: SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KI
HELENA LABORATORIES 510(k) NO: K061069(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 06-JUL-06
BEAUMONT, TX 77704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX
HEMCON, INC. 510(k) NO: K060363(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459
10575 SW CASCADE BLVD. SE DECISION MADE: 07-JUL-06
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223
DEVICE: HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RA
HOLOGIC, INC. 510(k) NO: K061561(TRADITIONAL)
ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 28-JUL-06
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEMENT BLOOD GLUCOSE TEST SYSTEM
HOME DIAGNOSTICS, INC. 510(k) NO: K060793(SPECIAL)
ATTN: KAREN DE VINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 25-JUL-06
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZE
HORIBA ABX 510(k) NO: K060205(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 33 4 67147320
PARC EUROMEDECINE SE DECISION MADE: 21-JUL-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: PCA 36MM FEMORAL HEADS
HOWMEDICA OSTEONICS CORP 510(k) NO: K061168(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 18-JUL-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT CONSTRAINED ACETABULAR INSERT
HOWMEDICA OSTEONICS CORP 510(k) NO: K061654(SPECIAL)
ATTN: JOSEPH VIOLA PHONE NO : 201-831-5379
325 CORPORATE DR. SE DECISION MADE: 07-JUL-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR PUREFIX HA SHOULDER
HOWMEDICA OSTEONICS CORP 510(k) NO: K061677(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 10-JUL-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPECTRA STO2 TISSUE OXYGENATION MONITOR
HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K061619(TRADITIONAL)
ATTN: THOMAS A DOLD PHONE NO : 320-587-1435
40 WEST HIGHLAND PARK SE DECISION MADE: 12-JUL-06
HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
I-STAT CORPORATION 510(k) NO: K053597(TRADITIONAL)
ATTN: SUE KENT PHONE NO : 609-443-9300
104 WINDSOR CENTER DRIVE SE DECISION MADE: 21-JUL-06
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-CAT SCANNER
IMAGING SCIENCES INTL., INC. 510(k) NO: K061284(TRADITIONAL)
ATTN: DAVID W COWAN PHONE NO : 215-997-5666
1910 NORTH PENN RD. SE DECISION MADE: 03-JUL-06
HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFORMANCE POSTS AND TEMPORARY CYLINDERS
IMPLANT INNOVATIONS, INC. 510(k) NO: K061969(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 21-JUL-06
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSORB ABSORBABLE STAPLE, MODEL 1020
INCISIVE SURGICAL, INC. 510(k) NO: K061784(SPECIAL)
ATTN: JAMES PETERSON PHONE NO : 952-591-2543
14405-21ST AVE. NORTH SE DECISION MADE: 26-JUL-06
PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
INOVEL LLC 510(k) NO: K061859(ABBREVIATED)
ATTN: WILLIAM WAWRZYNIAK PHONE NO : 866-546-6835
10111 W. JEFFERSON BLVD. SE DECISION MADE: 12-JUL-06
CULVER CITY, CA 90232-3509 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
INOVO, INC. 510(k) NO: K060751(TRADITIONAL)
ATTN: MICHAEL T DILDINE PHONE NO : 239-643-6577
2975 S. HORSESHOE DRIVE SE DECISION MADE: 18-JUL-06
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
NAPLES, FL 34104
DEVICE: MRGFUS GENERAL PURPOSE AND BREAST COIL
INSIGHTEC TXSONICS, INC. 510(k) NO: K061715(TRADITIONAL)
ATTN: NADIR ALIKACEM PHONE NO : 214-630-2000
2777 STEMMONS FREEWAY STE 940 SE DECISION MADE: 28-JUL-06
DALLAS, TX 75207-2273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K061640(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495
311 ENTERPRISE DR. SE DECISION MADE: 27-JUL-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA RADIONICS XKNIFE RT 4
INTEGRA RADIONICS, INC. 510(k) NO: K061893(SPECIAL)
ATTN: KEVIN O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVENUE SE DECISION MADE: 25-JUL-06
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORM OPERATING KIT, MODEL 1-10-0
INTELLIGENT ORTHOPAEDICS LTD 510(k) NO: K061607(TRADITIONAL)
ATTN: NEIL MC LACHLAN PHONE NO : 44 128 2617714
BRIERFIELD MILL SE DECISION MADE: 18-JUL-06
BRIERFIELD, NELSON, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFS CANNULATED BONE SCREW
INTERNAL FIXATION SYSTEMS, INC. 510(k) NO: K061620(TRADITIONAL)
ATTN: STEVE HERNANDEZ PHONE NO : 305-216-4766
5619 N.W. 74 AVENUE SE DECISION MADE: 26-JUL-06
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123
INVIVO 510(k) NO: K061952(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
3545 S.W. 47TH AVE. SE DECISION MADE: 28-JUL-06
GAINESVILLE, FL 32608 510(k) STATEMENT
DEVICE: IBA PROTON THERAPY SYSTEM - PROTEUS 235
ION BEAM APPLICATIONS S.A. 510(k) NO: K061913(SPECIAL)
ATTN: JOHN REISS PHONE NO : 215-972-7124
1500 MARKET STREET SE DECISION MADE: 28-JUL-06
CENTRE SQUARE WEST, 38TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19102
DEVICE: VIRTUAL
IVOCLAR VIVADENT, INC. 510(k) NO: K060891(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 17-JUL-06
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: COMPACT PLUS - EXTREME - PERFECT PLUS
J.O. SUAREZ & CIA, LTDA 510(k) NO: K052574(TRADITIONAL)
ATTN: JAVIER O SUAREZ PHONE NO : 551 141 910100
RUA SABURO SUMIYA, NO 241 SE DECISION MADE: 17-JUL-06
ALDEINHA, BARUERI, SP, BRAZIL 0644510(k) STATEMENT
DEVICE: KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K061180(TRADITIONAL)
ATTN: JAMES LEE PHONE NO : 310-410-5597
600 CORPORATE POINTE SE DECISION MADE: 27-JUL-06
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIACTIV FX EMBOLIC PROTECTION SYSTEM
KENSEY NASH CORP. 510(k) NO: K061772(TRADITIONAL)
ATTN: ROBIN M FATZINGER PHONE NO : 484-713-2100
735 PENNSYLVANIA AVE. SE DECISION MADE: 11-JUL-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KFX KNOTLESS FIXATION SYSTEM
KFX MEDICAL 510(k) NO: K061294(TRADITIONAL)
ATTN: MALCOLM HEAVEN PHONE NO : 610-270-8475
5145 AVENIDA ENCINAS, SUITE C SE DECISION MADE: 19-JUL-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
KHRUNICHEV STATE RESEARCH & PRODUC510(k) NO: K060739(SPECIAL)
ATTN: DANIEL JAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-JUL-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATARIUS, MODEL 001 003
KINETIC SURGICAL LLC 510(k) NO: K061292(TRADITIONAL)
ATTN: JIM CAPUTO PHONE NO : 760-943-8594
2157 VISTA LA NISA SE DECISION MADE: 03-JUL-06
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URGOTUL AG
LABORATOIRES URGO 510(k) NO: K061220(TRADITIONAL)
ATTN: SOPHIE FORTIN PHONE NO : 333 804 47967
42, RUE DE LONGVIC SE DECISION MADE: 27-JUL-06
CHENOVE, FRANCE 21300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL BALANCE LIQUID/ GEL
LACLEDE, INC. 510(k) NO: K061331(TRADITIONAL)
ATTN: MICHAEL A PELLICO PHONE NO : 310-605-4280
2103 EAST UNIVERSITY DR. SE DECISION MADE: 25-JUL-06
RANCHO DOMINQUEZ, CA 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY
LARSEN & TOUBRO LIMITED 510(k) NO: K061816(TRADITIONAL)
ATTN: HARRY P GUGNANI PHONE NO : 847-303-3906
1821 WALDEN OFFICE SQUARE SE DECISION MADE: 12-JUL-06
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
LIFE SPINE 510(k) NO: K061698(SPECIAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 12-JUL-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60195
DEVICE: CAREO SAFETY SYRINGE FOR U-100 INSULIN
LIFE-SHIELD PRODUCTS, INC 510(k) NO: K061055(ABBREVIATED)
ATTN: CHUNG-CHIH HSIAO PHONE NO : 886 222 996033
3F, NO 10, WUCHIUAN 7TH RD SE DECISION MADE: 10-JUL-06
WUGU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 248
DEVICE: LIV MEDICA CPR FACE MASK
LIV MEDICA PRODUCTS PVT. LTD. 510(k) NO: K052458(TRADITIONAL)
ATTN: MICHAEL HOLSTEIN PHONE NO : 302-235-2370
458 BRIARCREEK DRIVE SE DECISION MADE: 07-JUL-06
HOCKESSIN, DE 19707 510(k) STATEMENT
DEVICE: LMT NOMAG IC 3.0
LMT LAMMERS MEDICAL TECHNOLOGY GMB510(k) NO: K062052(TRADITIONAL)
ATTN: THOMAS M BOHNEN PHONE NO : 49 451 580980
OSTERWEIDE 8 SE DECISION MADE: 31-JUL-06
LUEBECK, GERMANY 23568 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
LUMENIS LTD. 510(k) NO: K060448(TRADITIONAL)
ATTN: MARTHA MURARI PHONE NO : 408-764-3604
2400 CONDENSA STREET SE DECISION MADE: 06-JUL-06
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL
MAQUET CARDIOPULMONARY AG 510(k) NO: K061743(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210
HECHINGER STRASSE 38 SE DECISION MADE: 21-JUL-06
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RADICAL 7 PULSE CO-OXIMETER
MASIMO CORPORATION 510(k) NO: K061204(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 27-JUL-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASKMEDIC CONCEPT NASAL MASK
MASKMEDIC 510(k) NO: K060067(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 14-JUL-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S
MEDCARE MANUFACTURING INC. 510(k) NO: K061694(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 05-JUL-06
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
MEDCHANNEL, LLC 510(k) NO: K060494(TRADITIONAL)
ATTN: FREDERICK TOBIA PHONE NO : 617-247-9266
55 WORCESTER STREET, #3 SE DECISION MADE: 03-JUL-06
BOSTON, MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTRA INJECTION NEEDLE
MEDI-GLOBE CORP. 510(k) NO: K061222(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772
110 WEST ORION, SUITE 136 SE DECISION MADE: 03-JUL-06
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
MEDICON, E.G. 510(k) NO: K053624(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 4289591
AMSTEL 320-I SE DECISION MADE: 17-JUL-06
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY MEDIUM, MODEL REF 1062
MEDICULT A/S 510(k) NO: K060983(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 28-JUL-06
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBEDDING TOOL, MODEL TE-1000
MEDIGROUP, INC. 510(k) NO: K060897(TRADITIONAL)
ATTN: JOHN A NEVIS PHONE NO : 630-554-5533
14 A STONEHILL RD. SE DECISION MADE: 18-JUL-06
OSWEGO, IL 60543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORAMATE/SPIROTOME SYSTEM
MEDINVENTS 510(k) NO: K060384(TRADITIONAL)
ATTN: MAGDA BUTTIENTS PHONE NO : 321 127 1557
KLEIN HILLSTSTRAAT 5 SE DECISION MADE: 13-JUL-06
HASSELT, LIMBURG, BELGIUM 3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE SYRINGES, MULTIPLE
MEDLINE INDUSTRIES, INC. 510(k) NO: K061275(ABBREVIATED)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 19-JUL-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K061304(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 18-JUL-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K061915(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-JUL-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K061592(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 03-JUL-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K053490(ABBREVIATED)
ATTN: STEVE CHAO PHONE NO : 886 4 23594985
9, ROAD 36 SE DECISION MADE: 24-JUL-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: MD-TEMP
META BIOMED CO., LTD. 510(k) NO: K061530(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 82 43 2718132
414-12 MOCHOONG-DONG SE DECISION MADE: 21-JUL-06
CHEONGJU CITY, CHUNGBUK, REPUBLIC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUFLO
MILESTONE SCIENTIFIC, INC. 510(k) NO: K053554(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW SE DECISION MADE: 10-JUL-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
MOBILIFE, LLC 510(k) NO: K061116(ABBREVIATED)
ATTN: STEVEN DUFRESNE PHONE NO :
78 ENTERPRISE ROAD SE DECISION MADE: 03-JUL-06
UNIT D 510(k) STATEMENT
DELAFIELD, WI 53018
DEVICE: MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
MP BIOMEDICALS, LLC. 510(k) NO: K051958(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE. SE DECISION MADE: 21-JUL-06
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFIX ANCHOR, 5.0 MM ANCHOR
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K061498(TRADITIONAL)
ATTN: NANCY L BENNEWITZ PHONE NO : 732-661-0202
125 MAY ST, STE 300 SE DECISION MADE: 06-JUL-06
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: NFIX FUSION SYSTEM
N-SPINE, INC. 510(k) NO: K053623(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 12-JUL-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHECKPOINT WITH ACCUSTIM TECHNOLOGY
NDI MEDICAL, LLC 510(k) NO: K061365(TRADITIONAL)
ATTN: JULIE GRILL PHONE NO : 919-968-4690
ONE CHAGRIN HIGHLANDS SE DECISION MADE: 12-JUL-06
2000 AUBURN DRIVE, SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44122
DEVICE: 21.3 INCH MONOCHROME LCD MONITOR
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K061947(TRADITIONAL)
ATTN: SHUICHI KINO PHONE NO : 81 465 852376
686-1 NISHIOI, OI-MACHI SE DECISION MADE: 25-JUL-06
ASHIGARAKAMI-GUN, KANAGAWA, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NESS L300
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K053468(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 07-JUL-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NC-STAT
NEUROMETRIX, INC. 510(k) NO: K060584(TRADITIONAL)
ATTN: RAINER N MAAS PHONE NO : 781-314-2781
62 FOURTH AVE. SE DECISION MADE: 31-JUL-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARGE UNI-CLIP STAPLE
NEWDEAL S.A. 510(k) NO: K061594(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 03-JUL-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KALIX II IMPLANT
NEWDEAL S.A. 510(k) NO: K061765(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 18-JUL-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWPORT E500 WAVE VENTILATOR
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K061094(SPECIAL)
ATTN: RICHARD WATERS PHONE NO : 714-427-5811
1620 SUNFLOWER AVE. SE DECISION MADE: 28-JUL-06
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOMOSSTAT, VERSION 1.0
NOMOS CORP. 510(k) NO: K060895(SPECIAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600
200 WEST KENSINGER DR. SE DECISION MADE: 21-JUL-06
SUITE 100 510(k) STATEMENT
CRANBERRY TOWNSHIP, PA 16066
DEVICE: SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC3
NOVASPINE LLC 510(k) NO: K061133(TRADITIONAL)
ATTN: HAMID KHOSROWSHAHI PHONE NO : 914-909-6577
PO BOX 969 SE DECISION MADE: 11-JUL-06
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL MESH SYSTEM
NUVASIVE, INC. 510(k) NO: K053215(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 17-JUL-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SPHERX II SYSTEM
NUVASIVE, INC. 510(k) NO: K061778(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 18-JUL-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE CARTRIDGE EXPRESS
NXSTAGE MEDICAL, INC. 510(k) NO: K061837(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 31-JUL-06
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
OMNIGUIDE, INC. 510(k) NO: K061909(TRADITIONAL)
ATTN: IRINA KULINETS PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 19-JUL-06
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: OR SPECIFIC BIG CASE BACK TABLE COVER
OR SPECIFIC, INC. 510(k) NO: K052668(TRADITIONAL)
ATTN: DANIEL BECKER PHONE NO : 407-292-4133
4651 36TH ST. #500 SE DECISION MADE: 24-JUL-06
ORLANDO, FL 32811 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
ORASURE TECHNOLOGIES, INC. 510(k) NO: K060859(SPECIAL)
ATTN: SUE SUTTON-JONES PHONE NO : 610-882-1820
150 WEBSTER ST. SE DECISION MADE: 18-JUL-06
BETHELEHEM, PA 18015-1389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRENGLOO
ORMCO CORP. 510(k) NO: K061481(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE SE DECISION MADE: 06-JUL-06
SUITE 6000 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92660
DEVICE: BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K060569(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 06-JUL-06
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
ORTHO ORGANIZERS, INC. 510(k) NO: K061266(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 31-JUL-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIB
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K060480(TRADITIONAL)
ATTN: LEAH VAN DE WATER PHONE NO : 585-453-4131
100 INDIGO CREEK DR. SE DECISION MADE: 03-JUL-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K061588(TRADITIONAL)
ATTN: MICHAEL BYRNE PHONE NO : 585-453-3143
100 INDIGO CREEK DR. SE DECISION MADE: 21-JUL-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIC SOURCE PRESS-FIT HIP
ORTHOPEDIC SOURCE INC. 510(k) NO: K061124(TRADITIONAL)
ATTN: J D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 18-JUL-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINPRO, BRAINPRO ACCESS
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K060808(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 770 492 91533
KARL-HALL-STRASSE 01 SE DECISION MADE: 25-JUL-06
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMA ANAESTHESIA MACHINE
PENLON LTD. 510(k) NO: K061102(SPECIAL)
ATTN: BARRY PEARCE PHONE NO : 011 441 243779550
25 BARKER CLOSE FISHBOURNE SE DECISION MADE: 28-JUL-06
CHICKESTER, UNITED KINGDOM P0188BJ510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
PINMED, INC 510(k) NO: K061977(TRADITIONAL)
ATTN: VLADIMIR SHUSTERMAN PHONE NO : 412-383-7096
245 MELWOOD AVE, #501 SE DECISION MADE: 21-JUL-06
PITTSBURG, PA 15213 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K061151(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 24-JUL-06
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-COR HIP REPLACEMENT SYSTEM
PORTLAND ORTHOPAEDICS PTY. LTD. 510(k) NO: K053417(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 20-JUL-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO-LINK BONE VOID FILLER PELLETS
PROMED ADVANCE TECHNOLOGY CO., LTD510(k) NO: K060809(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DRIVE SE DECISION MADE: 03-JUL-06
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYAIR
PROMEDIC, INC. 510(k) NO: K060497(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 11-JUL-06
#102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134
DEVICE: PULSION PICCO PLUS, MODEL 8100
PULSION MEDICAL SYSTEMS AG 510(k) NO: K060898(TRADITIONAL)
ATTN: JAMIE SULLEY PHONE NO : 919-562-4851
P.O. BOX 99033 SE DECISION MADE: 25-JUL-06
RALEIGH, NC 27624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
QUANTUM ORTHOPEDICS, INC. 510(k) NO: K061576(SPECIAL)
ATTN: JASON BLAIN PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 03-JUL-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D CBC-3D + CRP HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K061511(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 10-JUL-06
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIQUID PROTEIN CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K061056(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 20-JUL-06
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: APNEALINK, MODEL 22302
RESMED GERMANY INC. 510(k) NO: K061405(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 25-JUL-06
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
RESMED LTD. 510(k) NO: K061200(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 20-JUL-06
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHOLINESTERASE GEN.2 TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K061093(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 03-JUL-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K061683(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 21-JUL-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAVID PREGNANCY TEST (MIDSTREAM)
RUNBIO BIOTECH CO., LTD. 510(k) NO: K053236(TRADITIONAL)
ATTN: JESSICA VAGATA PHONE NO : 253-238-6409
2941 61ST. AVE NE SE DECISION MADE: 18-JUL-06
TACOMA, WA 98422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVITRO MATURATION MEDIA
SAGE IN-VITRO FERTILIZATION INC. 510(k) NO: K053646(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 14-JUL-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS VISICA TREATMENT SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K061510(SPECIAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-6080
4696 WILLOW RD. SE DECISION MADE: 18-JUL-06
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGAFIX INTERFERENCE SCREW
SCIENCES FOR BIO MATERIALS 510(k) NO: K061262(SPECIAL)
ATTN: DENIS CLEMENT PHONE NO : 33 562 422101
ZI DU MONGE SE DECISION MADE: 05-JUL-06
LOURDES, FRANCE F65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPION ULTRASONIC SCALING INSERTS
SCORPION 510(k) NO: K053578(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
333 MILFORD ROAD SE DECISION MADE: 14-JUL-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QMS TOBRAMYCIN
SERADYN, INC. 510(k) NO: K060998(TRADITIONAL)
ATTN: EARL E KNIGHT III PHONE NO : 317-554-0639
7998 GEORGETOWN RD., STE. 1000 SE DECISION MADE: 21-JUL-06
INDIANAPOLIS, IN 46268-5260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-220
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K061637(TRADITIONAL)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 25-JUL-06
TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K061641(TRADITIONAL)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 14-JUL-06
TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-120
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K061643(TRADITIONAL)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 27-JUL-06
TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYKRES SPINAL SYSTEM
SHOWA IKA KOHGYO CO.,LTD. 510(k) NO: K051704(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SUITE 20 SE DECISION MADE: 03-JUL-06
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO MULTIMODALITY WORKPLACE
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K061964(TRADITIONAL)
ATTN: SIEGLINDE WEST PHONE NO : 49 913 1843144
HENKESTRASSE 127 SE DECISION MADE: 27-JUL-06
ERLANGEN, BAVARIA, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNGO EXPERT-1
SIEMENS MEDICAL SOLUTION 510(k) NO: K061449(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PKWY. E-50 SE DECISION MADE: 25-JUL-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K061946(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 21-JUL-06
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW
DEVICE: SBI ULNAR HEAD IMPLANT
SMALL BONE INNOVATIONS INC. 510(k) NO: K061146(SPECIAL)
ATTN: ROBERT HOEHN PHONE NO : 215-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 19-JUL-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND W
SMART GLOVE CORP. SDN BHD 510(k) NO: K061724(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
BATU 5 3/4, JALAN KAPAR SE DECISION MADE: 25-JUL-06
KLANG 510(k) STATEMENT
SELANGOR DARUL ESHAN, MALAYSIA 42100
DEVICE: PATIENT MATCHED HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K053246(ABBREVIATED)
ATTN: LAURIE JORDAN PHONE NO : 901-399-5042
1450 BROOKS RD. SE DECISION MADE: 12-JUL-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
SMITH & NEPHEW, INC. 510(k) NO: K061011(ABBREVIATED)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 BROOKS RD. SE DECISION MADE: 11-JUL-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY HIP SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K061066(TRADITIONAL)
ATTN: JOHN REABE PHONE NO : 901-399-6670
1450 BROOKS RD. SE DECISION MADE: 14-JUL-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW MODULAR FEMORAL HEAD
SMITH & NEPHEW, INC. 510(k) NO: K061243(ABBREVIATED)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 BROOKS RD. SE DECISION MADE: 17-JUL-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
SMITH & NEPHEW, INC. 510(k) NO: K061569(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 E BROOKS ROAD SE DECISION MADE: 06-JUL-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAXX FX SYSTEM
SPINE WAVE, INC. 510(k) NO: K053336(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 03-JUL-06
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: AGILIS NXT STEERABLE INTRODUCER
ST. JUDE MEDICAL 510(k) NO: K061363(SPECIAL)
ATTN: GLENN JACQUES PHONE NO : 952-351-1356
14901 DEVEAU PL. SE DECISION MADE: 12-JUL-06
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BY
ST. JUDE MEDICAL 510(k) NO: K061710(SPECIAL)
ATTN: ADELE SHOUSTAL PHONE NO : 818-493-3268
15900 VALLEY VIEW CT. SE DECISION MADE: 14-JUL-06
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEAD BED
STEVEN H. WARNOCK, M.D. 510(k) NO: K060986(TRADITIONAL)
ATTN: STEVEN H WARNOCK PHONE NO : 801-571-2020
9829 S. 1300 E., SUITE 200 SE DECISION MADE: 11-JUL-06
SANDY, UT 84094 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX PINS
STRYKER HOWMEDICA OSTEONICS 510(k) NO: K061493(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 07-JUL-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K061854(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 27-JUL-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRULENE MESH
SUTURES INDIA PVT., LTD. 510(k) NO: K060018(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 041 868000
472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 26-JUL-06
PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
BANGALORE, INDIA 560058
DEVICE: SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
SYNTHES (USA) 510(k) NO: K061621(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948
1301 GOSHEN PKWY SE DECISION MADE: 27-JUL-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
SYSMEX AMERICA, INC. 510(k) NO: K061150(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 06-JUL-06
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K061181(TRADITIONAL)
ATTN: PI-SHIOU LI PHONE NO : 886 2 6635-8080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 06-JUL-06
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K061800(SPECIAL)
ATTN: PI-SHIOU LI PHONE NO : 886 2 66358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 07-JUL-06
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: POLYPLEX STIMULATING CATHETER SYSTEM
TE ME NA SAS 510(k) NO: K060186(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 18-JUL-06
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD C
TECO DIAGNOSTICS 510(k) NO: K061065(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 14-JUL-06
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTPILL GI MONITORING SYSTEM
THE SMARTPILL CORPORATION 510(k) NO: K053547(TRADITIONAL)
ATTN: KATHLEEN SELOVER PHONE NO : 716-882-0701
847 MAIN ST. SE DECISION MADE: 18-JUL-06
BUFFALO, NY 14203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
THERATEST LABORATORIES, INC. 510(k) NO: K061376(TRADITIONAL)
ATTN: MARIUS TEODORESCU, MD, PH.DPHONE NO : 630-627-6069
1111 N. MAIN ST. SE DECISION MADE: 20-JUL-06
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: TCS UNBREAKABLE
THERMOPLASTIC COMFORT SYSTEMS, INC510(k) NO: K053060(TRADITIONAL)
ATTN: MARILIN POSCA PHONE NO : 562-462-2970
2075 E. 27TH ST. SE DECISION MADE: 20-JUL-06
SIGNAL HILL, CA 90755 510(k) STATEMENT
DEVICE: SPI ART ABUTMENTS
THOMMEN MEDICAL, AG 510(k) NO: K061807(TRADITIONAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 31-JUL-06
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
TISSUE TECHNOLOGIES HOLDINGS, LLC 510(k) NO: K061060(TRADITIONAL)
ATTN: MARK LICATA PHONE NO : 804-828-9329
800 EAST LEIGH STREET SE DECISION MADE: 03-JUL-06
RICHMOND, VA 23219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIVA
TOMOGRAPHIX IP LTD. 510(k) NO: K061418(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 21-JUL-06
STAMFORD, CT 06907-1659 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPSLANE DMLC
TOPSLANE INTERNATIONAL, LLC 510(k) NO: K060187(TRADITIONAL)
ATTN: JIM MARSH PHONE NO : 727-507-8500
15375 ROOSEVELT BLVD. SE DECISION MADE: 27-JUL-06
SUITE # 300 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33760
DEVICE: AEQUALIS REVERSED PROSTHESIS
TORNIER 510(k) NO: K061439(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 00 33 476613898
161 RUE LAVOISIER SE DECISION MADE: 20-JUL-06
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K061447(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469
300 OYA, UEDA SE DECISION MADE: 21-JUL-06
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
TRIMENSA PHARMACEUTICALS 510(k) NO: K051688(TRADITIONAL)
ATTN: ROBIN J OGILVIE PHONE NO : 800-554-1313
1050 LAWRENCE DR. SE DECISION MADE: 12-JUL-06
NEWBURY PARK, CA 91320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
TROKAMED GMBH 510(k) NO: K060232(TRADITIONAL)
ATTN: KARLHEINZ TRONDLE PHONE NO : 490 770 492440
KLEINE BREITE 17 SE DECISION MADE: 12-JUL-06
GEISINGEN, GERMANY 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
TROKAMED GMBH 510(k) NO: K060233(TRADITIONAL)
ATTN: KARLHEINZ TRONDLE PHONE NO : 490 770 492440
KLEINE BREITE 17 SE DECISION MADE: 19-JUL-06
GEISINGEN, GERMANY 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSO3 OZONE STERILIZER, MODEL 125L
TSO3 INC. 510(k) NO: K051595(TRADITIONAL)
ATTN: CHARLES O HANCOCK PHONE NO : 585-223-1850
33 BLACK WATCH TRAIL SE DECISION MADE: 26-JUL-06
FAIRPORT, NY 14450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
TUNG FU ELECTRIC CO., LTD. 510(k) NO: K061452(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 2 66358080
4F, NO. 88, SEC. 1 SE DECISION MADE: 12-JUL-06
KWANG FU ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SAN CHUNG, CHINA (TAIWAN) 241
DEVICE: TYRX ANTIMICROBIAL MESH
TYRX PHARMA INC 510(k) NO: K053656(TRADITIONAL)
ATTN: MASON W DIAMOND PHONE NO : 732-246-8676
1 DEER PARK DR SE DECISION MADE: 14-JUL-06
SUITE G 510(k) SUMMARY AVAILABLE FROM FDA
MONMOUTH JUNCTION, NJ 08852
DEVICE: E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K061769(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 03-JUL-06
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: INTUITION INFUSION SETS
UNOMEDICAL A/S 510(k) NO: K061374(TRADITIONAL)
ATTN: RABI GHARABLI PHONE NO : 45 46 427860
AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 31-JUL-06
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
UROPLASTY, INC. 510(k) NO: K061333(SPECIAL)
ATTN: LISA GALLATIN PHONE NO : 612-378-9399
2718 SUMMER ST. NE SE DECISION MADE: 03-JUL-06
MINNEAPOLIS, MN 55413-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-LIX TISSUE GRASPER
USGI MEDICAL 510(k) NO: K061268(TRADITIONAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890
1140 CALLE CORDILLERA SE DECISION MADE: 31-JUL-06
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARISOURCE 200 HDR AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K061582(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY M/S E-110 SE DECISION MADE: 25-JUL-06
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEATHERLITE AQUA TOCODYNAMOMETER
VENTREX, INC. 510(k) NO: K061044(TRADITIONAL)
ATTN: GEORGE AUSTRIA PHONE NO : 805-658-2984
3007 BUNSEN AVE. SE DECISION MADE: 12-JUL-06
SUITE K 510(k) SUMMARY AVAILABLE FROM FDA
VENTURA, CA 93003
DEVICE: VERESURE BELL
VERESURE, INC. 510(k) NO: K061387(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVE. SE DECISION MADE: 21-JUL-06
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-CONNECT
VIDACARE CORPORATION 510(k) NO: K061771(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 10-JUL-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
VOCO GMBH 510(k) NO: K061823(SPECIAL)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 21-JUL-06
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: VYCOR SURGICAL ACCESS SYSTEMS
VYCOR MEDICAL LLC 510(k) NO: K060973(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 26-JUL-06
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K061547(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 03-JUL-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALLOMATRIX CUSTOM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K061939(SPECIAL)
ATTN: BRIAN YOUNG PHONE NO : 901-867-4120
5677 AIRLINE RD. SE DECISION MADE: 18-JUL-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K061553(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-JUL-06
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
Z-MEDICA CORPORATION 510(k) NO: K061767(SPECIAL)
ATTN: ROBERT V PACKARD PHONE NO : 203-294-0000
4 FAIRFIELD BLVD. SE DECISION MADE: 19-JUL-06
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
ZIEHM IMAGING, INC. 510(k) NO: K061310(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-718-2020
4181 LATHAM ST. SE DECISION MADE: 07-JUL-06
RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
ZIEHM IMAGING, INC. 510(k) NO: K061534(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-718-2020
4181 LATHAM ST. SE DECISION MADE: 07-JUL-06
RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGIT SURGICAL DEVICE
ZIMMER INC. 510(k) NO: K060556(TRADITIONAL)
ATTN: TONI KINGSLEY PHONE NO : 574-372-4485
345 E. MAIN ST. SE DECISION MADE: 31-JUL-06
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K061786(SPECIAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354
P.O. BOX 708 SE DECISION MADE: 24-JUL-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 277
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 30
Updated September 13, 2006
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