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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-FEB-2006 THROUGH 28-FEB-2006
DEVICE: BOVIE BUTTON REMOTE HAND SWITCH
AARON MEDICAL INDUSTRIES 510(k) NO: K060117(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 22-FEB-06
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MOD
ABRACAIR, INC. 510(k) NO: K052732(TRADITIONAL)
ATTN: DAVID CHANGARIS PHONE NO : 502-584-6852
801 BARRET AVENUE SE DECISION MADE: 24-FEB-06
LOUSVILLE, KY 40204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP00100
ACRO BIOTECH LLC. 510(k) NO: K053032(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749
9500 7TH STREET UNIT M SE DECISION MADE: 09-FEB-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 90
ADVANCED BIO-SURFACES, INC. 510(k) NO: K053094(TRADITIONAL)
ATTN: PHILLIP B JARVI PHONE NO : 952-912-5400
5909 BAKER ROAD, SUITE 550 SE DECISION MADE: 06-FEB-06
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAESTRO MDTL LASER SYSTEM
ADVANCED MEDICAL TECHNOLOGIES, INC510(k) NO: K053473(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD., #A SE DECISION MADE: 03-FEB-06
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP STERILCONTAINER SYSTEM
AESCULAP, INC. 510(k) NO: K053389(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 15-FEB-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLUMBUS (CR) TOTAL KNEE SYSTEM
AESCULAP, INC. 510(k) NO: K053390(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 06-FEB-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO S4 SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K060152(SPECIAL)
ATTN: LISA BOYLE PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 03-FEB-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESKULISA GLIA A AND AESKULISA GLIA G
AESKU.DIAGNOSTICS 510(k) NO: K052439(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057
8880 NW 18TH TERRACE SE DECISION MADE: 07-FEB-06
MIAMI, FL 33172 510(k) STATEMENT
DEVICE: REPROCESSED COMPRESSION SLEEVES
ALLIANCE MEDICAL CORP. 510(k) NO: K053316(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350
10232 SOUTH 51ST ST. SE DECISION MADE: 13-FEB-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED COMPRESSION SLEEVES
ALLIANCE MEDICAL CORP. 510(k) NO: K060049(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350
10232 SOUTH 51ST ST. SE DECISION MADE: 24-FEB-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
ALLIANCE MEDICAL CORP. 510(k) NO: K060091(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 17-FEB-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
ALTATEC GMBH 510(k) NO: K051636(ABBREVIATED)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-843-5753
520 SOUTH ROCK BLVD. SE DECISION MADE: 17-FEB-06
RENO, NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR II SPINAL SYSTEM
ALTIVA CORP. 510(k) NO: K053070(TRADITIONAL)
ATTN: JOHN KAPTIAN PHONE NO : 704-409-1754
9800-I SOUTHERN PINE BLVD. SE DECISION MADE: 13-FEB-06
CHARLOTTE, NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARX SPINAL SYSTEM
AMEDICA CORP. 510(k) NO: K051525(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 801-583-5100
615 ARAPEEN DRIVE SE DECISION MADE: 17-FEB-06
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84108
DEVICE: AMS MALE TRANSOBTURATOR SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K053371(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 952-933-4666
10700 BREN RD., WEST SE DECISION MADE: 03-FEB-06
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
ANDANTE MEDICAL DEVICES LTD. 510(k) NO: K060150(SPECIAL)
ATTN: DORIT WINITZ PHONE NO : 972 361 23281
7 JABOTINSKY STREET (MOSHE SE DECISION MADE: 23-FEB-06
AVIV TOWER) 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT GAN, ISRAEL 52520
DEVICE: INTERFACE
APEX DENTAL MATERIALS, INC. 510(k) NO: K053103(ABBREVIATED)
ATTN: CHRIS KULTON PHONE NO : 877-273-9123
23329 MALLARD COURT SE DECISION MADE: 01-FEB-06
DEER PARK, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZLOC FEMORAL FIXATION DEVICE
ARTHROTEK, INC. 510(k) NO: K053461(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 03-FEB-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (
ARTRON LABORATORIES, INC. 510(k) NO: K060019(TRADITIONAL)
ATTN: JERRY ZHENG PHONE NO : 604 415 9757
3938 NORTH FRASER WAY SE DECISION MADE: 17-FEB-06
BURNABY, BRITISH COLUMBIA, CANADA 510(k) STATEMENT
DEVICE: HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SY
BAXTER HEALTHCARE CORP. 510(k) NO: K053512(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD SE DECISION MADE: 16-FEB-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
BECKMAN COULTER, INC. 510(k) NO: K060130(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 13-FEB-06
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K060256(SPECIAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 S. KRAEMER BLVD. SE DECISION MADE: 27-FEB-06
BREA, CA 92622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANDLEX, MODEL P100X
BESTEAM TECHNOLOGY INC. 510(k) NO: K060042(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 422 465396
16F-2, NO.462, SEC. 2 SE DECISION MADE: 14-FEB-06
CHONG-DE RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEITUN DISTRICT, TAICHUNG, CHINA (TAIWAN) 40653
DEVICE: BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K053099(TRADITIONAL)
ATTN: WINSTON GREER PHONE NO : 205-986-1205
ONE PERIMETER PARK SOUTH SE DECISION MADE: 14-FEB-06
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: CURAY CUSTOM SEED ARRAY
BIOLUCENT, INC. 510(k) NO: K053595(TRADITIONAL)
ATTN: SHERYL HIGGINS PHONE NO : 949-349-1380
6 JOURNEY, SUITE 325 SE DECISION MADE: 28-FEB-06
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSS-BODIES PROXIMAL TIBIAL SLEEVE
BIOMET MANUFACTURING CORP. 510(k) NO: K060131(SPECIAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 15-FEB-06
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: XR-SERIES BI-METRIC FEMORAL COMPONENTS
BIOMET MANUFACTURING, INC. 510(k) NO: K052089(SPECIAL)
ATTN: PATRICIA SANDBORN-BERES PHONE NO : 574-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 17-FEB-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
BIONIME CORPORATION 510(k) NO: K053635(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 21-FEB-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KORLEX-GR GINGIVAL RETRACTION PASTE
BIOTECH ONE, INC. 510(k) NO: K053329(TRADITIONAL)
ATTN: KAREN UYESUGI PHONE NO : 949-661-1271
92 COSTA BRAVA SE DECISION MADE: 15-FEB-06
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCM
BL HEALTHCARE, INC. 510(k) NO: K052608(TRADITIONAL)
ATTN: MICHAEL MATHUR PHONE NO : 508-543-4150
33 COMMERCIAL ST., SUITE #3 SE DECISION MADE: 01-FEB-06
FOXBORO, MA 02035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K060350(SPECIAL)
ATTN: WHITNEY G TURNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 24-FEB-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: TRANSET SYSTEM
BONUTTI RESEARCH, INC. 510(k) NO: K060283(SPECIAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
2600 SOUTH RANEY SE DECISION MADE: 22-FEB-06
P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401
DEVICE: FRAMELESS RADIOSURGERY COMPONENTS
BRAINLAB AG 510(k) NO: K053500(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 03-FEB-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CI KNEE, CI MI TKR
BRAINLAB, AG 510(k) NO: K052966(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 13-FEB-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN
BRAINLAB, AG 510(k) NO: K053127(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 09-FEB-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
BRENNEN MEDICAL, INC. 510(k) NO: K050086(TRADITIONAL)
ATTN: KENNETH B HERLAND PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 17-FEB-06
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-SLING
CALDERA MEDICAL, INC. 510(k) NO: K050516(TRADITIONAL)
ATTN: MARLA KENGEN PHONE NO : 866-422-5337
28632 ROADSIDE DR., SUITE 260 SE DECISION MADE: 03-FEB-06
AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POPMESH
CALDERA MEDICAL, INC. 510(k) NO: K053424(TRADITIONAL)
ATTN: MARLA KENGEN PHONE NO : 866-422-5337
28632 ROADSIDE DR., SUITE 260 SE DECISION MADE: 22-FEB-06
AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALDERA MESH
CALDERA MEDICAL, INC. 510(k) NO: K060004(TRADITIONAL)
ATTN: MARLA KENGEN PHONE NO : 866-422-5337
28632 ROADSIDE DR., SUITE 260 SE DECISION MADE: 22-FEB-06
AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBONAID GAS DIFFUSER
CARDIA INNOVATION AB 510(k) NO: K052125(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
7307 GLOCHESTER DRIVE SE DECISION MADE: 08-FEB-06
EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARA I-RESPONSE CEDARA PET/CT
CEDARA SOFTWARE CORP. 510(k) NO: K053301(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 03-FEB-06
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
CHATTANOOGA GROUP 510(k) NO: K053223(TRADITIONAL)
ATTN: MICHAEL TREAS PHONE NO : 423-870-7209
4717 ADAMS RD. SE DECISION MADE: 24-FEB-06
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
HIXSON, TN 37343
DEVICE: FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PR
CHEMENCE MEDICAL INC. 510(k) NO: K050757(TRADITIONAL)
ATTN: SCOTT LEAL PHONE NO : 770-664-6624
185 BLUEGRASS VALLEY PKWY. SE DECISION MADE: 23-FEB-06
ALPHARETTA, GA 30005-2222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC. 510(k) NO: K060008(SPECIAL)
ATTN: CHRIS SCAVOTTO PHONE NO : 763-463-4621
7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 02-FEB-06
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADI
CHUNG CHENG ELECTRIC HEATING CO., 510(k) NO: K053376(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
2904 N. BOLDT DRIVE SE DECISION MADE: 16-FEB-06
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
CHURCH & DWIGHT CO., INC. 510(k) NO: K050828(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748
469 NORTH HARRISON STREET SE DECISION MADE: 28-FEB-06
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
CIVENT COMMUNICATIONS LTD 510(k) NO: K051175(TRADITIONAL)
ATTN: RUDI LOKITS PHONE NO : 972 3 6962240
MESHEK 58 SE DECISION MADE: 17-FEB-06
BEN NNATAN 510(k) SUMMARY AVAILABLE FROM FDA
MOSHAV HEMED, ISRAEL 50295
DEVICE: PEDIATRIC URINARY CATHETER
CLAY KENNARD 510(k) NO: K060268(TRADITIONAL)
ATTN: CLAY KENNARD PHONE NO : 405-840-4224
2909 BROWNE STONE ROAD SE DECISION MADE: 24-FEB-06
OKLAHOMA CITY, OK 73120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
CLINICAL DATA, INC. 510(k) NO: K052591(TRADITIONAL)
ATTN: ISRAEL M STEIN PHONE NO : 617-527-9933
ONE GATEWAY CENTER, SUITE 411 SE DECISION MADE: 09-FEB-06
NEWTON, MA 02146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIX -PLUS
COLBAR LIFESCIENCE LTD. 510(k) NO: K053260(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 22-FEB-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MINI REVO SUTURE ANCHOR
CONMED LINVATEC 510(k) NO: K053561(TRADITIONAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 23-FEB-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POCKET BREATHALYZER. CONNECTABLES
CONNECTABLES, LLC 510(k) NO: K052448(TRADITIONAL)
ATTN: PHILLIP H CORSE PHONE NO : 847-778-7107
2340 ERNIE KRUEGER CIRCLE SE DECISION MADE: 23-FEB-06
WAUKEGAN, IL 60087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.
COOK, INC. 510(k) NO: K060174(SPECIAL)
ATTN: EVANGELINE D LOH PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 17-FEB-06
BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSIN
COVALON TECHNOLOGIES LTD. 510(k) NO: K052696(TRADITIONAL)
ATTN: JACQUES LEMMETTI PHONE NO : 704-243-3059
2033 IVERSON LANES SE DECISION MADE: 03-FEB-06
WAXHAW, NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIELLE LUBRICANT
CST MEDICAL LIMITED 510(k) NO: K051288(TRADITIONAL)
ATTN: CHRISTIAN SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN SE DECISION MADE: 03-FEB-06
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CROFTON, MD 21114
DEVICE: YAG MIR FAMILY LASER
CYNOSURE, INC. 510(k) NO: K053421(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 01-FEB-06
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA V-STAR LASER
CYNOSURE, INC. 510(k) NO: K053608(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 13-FEB-06
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
DADE BEHRING, INC. 510(k) NO: K053061(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101 SE DECISION MADE: 06-FEB-06
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC1
DADE BEHRING, INC. 510(k) NO: K053108(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101, M/S 514 SE DECISION MADE: 16-FEB-06
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERY
DADE BEHRING, INC. 510(k) NO: K053504(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 24-FEB-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K053576(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 07-FEB-06
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICI
DADE BEHRING, INC. 510(k) NO: K060088(TRADITIONAL)
ATTN: ROBERT C EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 03-FEB-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRID
DADE BEHRING, INC. 510(k) NO: K060090(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 27-FEB-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUP
DAXIN LI 510(k) NO: K052731(TRADITIONAL)
ATTN: YINGCHAO XIAO PHONE NO : 626-799-0998
2600 MISSION STREET, SUITE 100 SE DECISION MADE: 01-FEB-06
SAN MARINO, CA 91108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTIUM ABUTMENTS
DENTIUM, INC. 510(k) NO: K052823(ABBREVIATED)
ATTN: KLAAS BESSELING PHONE NO : 949-466-7472
28711 JAEGER DRIVE SE DECISION MADE: 21-FEB-06
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY CROWN AND BRIDGE MATERIAL
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K060293(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 17-FEB-06
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: AEGIS ANTERIOR LUMBAR PLATE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K052546(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DR. SE DECISION MADE: 03-FEB-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE/IMMULITE 1000 TURBO INTACT PTH
DIAGNOSTIC PRODUCTS CORPORATION 510(k) NO: K053533(TRADITIONAL)
ATTN: DEBORAH L MORRIS PHONE NO : 310-645-8200
5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 03-FEB-06
LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
DIASORIN S.P.A. 510(k) NO: K052499(TRADITIONAL)
ATTN: MARI A MEYER PHONE NO : 651-351-5635
1951 NORTHWESTERN AVE. SE DECISION MADE: 08-FEB-06
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082-0285
DEVICE: MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
DIAZYME LABORATORIES 510(k) NO: K053566(SPECIAL)
ATTN: HUAN TRAN PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT. SE DECISION MADE: 15-FEB-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DART-12
DIREX SYSTEMS CORP. 510(k) NO: K052705(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837
11 MERCER RD. SE DECISION MADE: 21-FEB-06
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
DRAEGER MEDICAL AG & CO. KGAA 510(k) NO: K053204(SPECIAL)
ATTN: MONICA FERRANTE PHONE NO : 215-721-5400
3155 QUARRY ROAD SE DECISION MADE: 03-FEB-06
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY GAMMA / GAMMAXL, INFINITY VISTA
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K053484(SPECIAL)
ATTN: KAREN A LORIO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 22-FEB-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK PACS
EASTMAN KODAK COMPANY 510(k) NO: K060055(TRADITIONAL)
ATTN: CAROLYN L WAGNER PHONE NO : 585-724-4487
343 STATE STREET SE DECISION MADE: 07-FEB-06
ROCHESTER, NY 14650 510(k) STATEMENT
DEVICE: KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
EASTMAN KODAK COMPANY 510(k) NO: K060079(SPECIAL)
ATTN: RAVI NABAR PHONE NO : 585-781-9457
343 STATE ST. SE DECISION MADE: 08-FEB-06
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRES
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K053609(TRADITIONAL)
ATTN: DIANE PETERSON PHONE NO : 949-250-3514
ONE EDWARDS WAY SE DECISION MADE: 28-FEB-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LYSUS INFUSION SYSTEM
EKOS CORP. 510(k) NO: K060084(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 07-FEB-06
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: DISC-FX SYSTEM
ELLMAN INTERNATIONAL, INC. 510(k) NO: K052241(TRADITIONAL)
ATTN: JOAN CARTER PHONE NO : 516-267-6522
3333 ROYAL AVENUE SE DECISION MADE: 24-FEB-06
OCEANSIDE, NY 11572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE CS SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K060279(SPECIAL)
ATTN: ALDEN KAY PHONE NO : 949-450-5424
201 TECHNOLOGY DR. SE DECISION MADE: 28-FEB-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED UROLOGICAL CATHETER
ENTRACARE, LLC 510(k) NO: K053429(TRADITIONAL)
ATTN: AL BOEDEKER PHONE NO : 913-451-2234
11315 STRANG LINE RD. SE DECISION MADE: 08-FEB-06
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMASTREAM
ENZYSURGE, LTD. 510(k) NO: K060046(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 27-FEB-06
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX EPIDURAL NEEDLE
EPIMED INTERNATIONAL, INC. 510(k) NO: K053318(TRADITIONAL)
ATTN: CHRISTOPHER LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DR. SE DECISION MADE: 17-FEB-06
CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
JOHNSTOWN, NY 12095
DEVICE: ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
ERBE USA, INC. 510(k) NO: K060170(SPECIAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 16-FEB-06
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PR
ERBE USA, INC. 510(k) NO: K060183(SPECIAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2225 NORTHWEST PARKWAY SE DECISION MADE: 16-FEB-06
MARIETTA, GA 30157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN H
EUROIMMUN US LLC 510(k) NO: K051489(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
TEK CAMPUS OF MORRIS COUNTY SE DECISION MADE: 16-FEB-06
429 ROCKAWAY VALLEY RD. 510(k) STATEMENT
BOONTON TWP, NJ 07005
DEVICE: SPIDERX EMBOLIC PROTECTION DEVICE
EV3 INC 510(k) NO: K052659(TRADITIONAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 17-FEB-06
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BERRY FRUITY TEETHER
EVENFLO COMPANY, INC. 510(k) NO: K053493(TRADITIONAL)
ATTN: RUBEN D COLMENARES PHONE NO : 937-415-3288
707 CROSSROADS COURT SE DECISION MADE: 22-FEB-06
VANDALIA, OH 45377 510(k) STATEMENT
DEVICE: OPTECURE
EXACTECH, INC. 510(k) NO: K050806(TRADITIONAL)
ATTN: REBECCA S ROBERTS PHONE NO : 352-264-8890
2320 N.W. 66TH CT. SE DECISION MADE: 08-FEB-06
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
EXACTECH, INC. 510(k) NO: K060107(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 06-FEB-06
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK NEUROPATH, MODEL PK1070
EXCEL TECH. LTD. 510(k) NO: K053058(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 07-FEB-06
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
FEMSPEC L.L.C. 510(k) NO: K052192(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 360-379-3660
1530 HOLCOMB STREET SE DECISION MADE: 02-FEB-06
PORT TOWNSEND, WA 98368 510(k) STATEMENT
DEVICE: FOTONA QX ND:YAG/KTP LASER SYSTEM
FOTONA D.D. 510(k) NO: K053139(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 1 5009299
STEGNE 7, SE DECISION MADE: 16-FEB-06
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
GALIL MEDICAL LTD. 510(k) NO: K060144(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 13-FEB-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E
GE HEALTHCARE 510(k) NO: K051217(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 03-FEB-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 212
GE MEDICAL SYSTEMS, LLC 510(k) NO: K060259(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N GRANDVIEW BLVD. SE DECISION MADE: 22-FEB-06
W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: GENZYME OSOM INFLUENZA A & B TEST
GENZYME CORP. 510(k) NO: K051244(TRADITIONAL)
ATTN: FRED D LASKY PHONE NO : 617-591-5512
500 KENDALL STREET SE DECISION MADE: 21-FEB-06
CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, C
GOOD BIOTECH CORP. 510(k) NO: K052617(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873
38, 34TH RD. SE DECISION MADE: 23-FEB-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
GRANTADLER CORPORTATION 510(k) NO: K043178(TRADITIONAL)
ATTN: MICHAEL LOITERMAN PHONE NO : 630-302-4944
1994 BANBURY AVENUE SE DECISION MADE: 02-FEB-06
YORKVILLE, IL 60560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
GRANTON MEDICAL LTD. 510(k) NO: K052665(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 27-FEB-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRT LITE, MODEL 8-A
GRT SOLUTIONS, INC. 510(k) NO: K050668(TRADITIONAL)
ATTN: GEORGE GONZALEZ PHONE NO : 323-653-2818
425 GARDNER ST. SE DECISION MADE: 03-FEB-06
LOS ANGELES, CA 90036-5732 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
GUIDANT CORPORATION 510(k) NO: K052965(TRADITIONAL)
ATTN: LINDA KLEINSASSER PHONE NO : 651-582-4106
4100 HAMLINE AVE NORTH SE DECISION MADE: 13-FEB-06
ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOULDER FIXATION SYSTEM
HAND INNOVATIONS, LLC. 510(k) NO: K060290(SPECIAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899
8905 SW 87TH AVENUE SE DECISION MADE: 27-FEB-06
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
HEMOCUE AB 510(k) NO: K053253(TRADITIONAL)
ATTN: ALLAN WHITE PHONE NO : 800-881-1611
40 EMPIRE DRIVE SE DECISION MADE: 17-FEB-06
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CXR16
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K053148(ABBREVIATED)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-FEB-06
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HOCA EZ-CARE BP108, TENDER-CARE BP109
HOCA MEDICAL MICROSYSTEM, INC. 510(k) NO: K052671(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 03-FEB-06
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
HOSPIRA, INC. 510(k) NO: K052828(SPECIAL)
ATTN: THOMAS KOZMA PHONE NO : 224-212-4803
275 NORTH FIELD DR. SE DECISION MADE: 17-FEB-06
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
HU-FRIEDY MFG. CO.,INC. 510(k) NO: K053178(TRADITIONAL)
ATTN: KEITH DUNN PHONE NO : 773-975-3975
3232 NORTH ROCKWELL ST. SE DECISION MADE: 01-FEB-06
CHICAGO, IL 60618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K053618(TRADITIONAL)
ATTN: JOSEPH P ORTNER PHONE NO : 320-587-1435
40 WEST HIGHLAND PARK SE DECISION MADE: 08-FEB-06
HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FO
HYGIA HEALTH SERVICES, INC. 510(k) NO: K053575(TRADITIONAL)
ATTN: KYLE FERGUSON PHONE NO : 205-314-3920
434 INDUSTRIAL LN. SE DECISION MADE: 15-FEB-06
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILLCARE, MODEL GW-1020
ICU MEDICAL INC 510(k) NO: K052594(TRADITIONAL)
ATTN: SCOTT NELSON PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 10-FEB-06
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128 THIRD PARTY REVIEW
DEVICE: PREFORMANCE POSTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K053170(TRADITIONAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 01-FEB-06
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFORMANCE TEMPORARY CYLINDER
IMPLANT INNOVATIONS, INC. 510(k) NO: K060291(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 27-FEB-06
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE NATURAL RUBBER LATEX CONDOM
INNOLATEX SDN. BHD 510(k) NO: K053367(ABBREVIATED)
ATTN: GOH MIAH KIAT PHONE NO : 603 316 81613
PANDAMARAN INDUSTRIAL ESTATE SE DECISION MADE: 21-FEB-06
PORT KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42000
DEVICE: SLACTIVE IMPLANTS
INSTITUT STRAUMANN AG 510(k) NO: K053088(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 27-FEB-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN ORTHOSYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K060062(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 03-FEB-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL ELITE; ACL ELITE PRO
INSTRUMENTATION LABORATORY CO. 510(k) NO: K060162(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 21-FEB-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENDON WRAP TENDON PROTECTOR
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K053655(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-936-2240
311 ENTERPRISE DR. SE DECISION MADE: 03-FEB-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISSYS DRUG FLOW MONITOR
INTEGRATED SENSING SYSTEMS, INC. 510(k) NO: K050783(TRADITIONAL)
ATTN: STEPHEN GOLDNER, JD, RAC PHONE NO : 248-855-5595
391 AIRPORT INDUSTRIAL DRIVE SE DECISION MADE: 22-FEB-06
YPSILANTI, MI 48198 510(k) STATEMENT
DEVICE: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SE
INVERNESS MEDICAL INNOVATIONS, INC510(k) NO: K060133(TRADITIONAL)
ATTN: JAMES M DELANEY PHONE NO : 978-475-5692
51 SAWYER RD., SUITE 200 SE DECISION MADE: 16-FEB-06
WALTHAM, MA 02453-3448 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCAS
JOLIFE AB 510(k) NO: K053403(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5600
555 13TH ST. NW SE DECISION MADE: 01-FEB-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNODENT 2190 WITH PERIODONTAL PROBE
KAVO DENTAL CORPORATION 510(k) NO: K060080(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 08-FEB-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
KCI USA, INC. 510(k) NO: K053627(TRADITIONAL)
ATTN: CHRISTY H OVIATT PHONE NO : 210-255-6105
8023 VANTAGE DR. SE DECISION MADE: 06-FEB-06
SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-00
KLS-MARTIN L.P. 510(k) NO: K060097(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 27-FEB-06
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K052450(TRADITIONAL)
ATTN: LIU YI PHONE NO : 862 260 526082
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 28-FEB-06
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K052676(TRADITIONAL)
ATTN: LIU YI PHONE NO : 862 260 526082
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 17-FEB-06
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: TITAN STEERABLE (PTCA) GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K052347(TRADITIONAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 17-FEB-06
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEONE IMPLANT SYSTEM
LEONE SPA 510(k) NO: K050586(ABBREVIATED)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 27-FEB-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ES-160
LHASA OMS, INC. 510(k) NO: K051020(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072
230 LIBBEY PKWY. SE DECISION MADE: 24-FEB-06
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
LIFE-TECH, INC. 510(k) NO: K052954(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 15-FEB-06
STAFFORD, TX 77477-3995 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
MAKO SURGICAL CORP. 510(k) NO: K060017(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2901 SIMMS STREET SE DECISION MADE: 23-FEB-06
HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARCH HEALTHCARE HEALTH MONITORING KIT
MARCH HEALTHCARE CORPORATION 510(k) NO: K060194(TRADITIONAL)
ATTN: TIMON LEDAIN PHONE NO : 613 591 6469
555 LEGGET DR, TOWER B SE DECISION MADE: 13-FEB-06
SUITE 222 510(k) SUMMARY AVAILABLE FROM FDA
OTTAWA, ONTARIO, CANADA K2K 2X3 THIRD PARTY REVIEW
DEVICE: SIMPLANT DR. JAMES
MATERIALISE N.V. 510(k) NO: K053592(SPECIAL)
ATTN: CARL VAN LIERDE PHONE NO : 32 163 96714
15 TECHNOLOGIELAAN SE DECISION MADE: 08-FEB-06
LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPORT
MAXANT TECHNOLOGIES, INC. 510(k) NO: K060210(TRADITIONAL)
ATTN: DONALD P DEVALE PHONE NO : 847-588-2280
7540 CALDWELL AVE SE DECISION MADE: 10-FEB-06
NILES, IL 60714 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: K-Y BRAND SENSUAL MIST
MCNEIL-PPC, INC. 510(k) NO: K053397(SPECIAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730
199 GRANDVIEW RD. SE DECISION MADE: 17-FEB-06
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE
MEDLINE INDUSTRIES, INC. 510(k) NO: K052168(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 16-FEB-06
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE-TEX NON-STERILE SURGICAL GOWNS
MEDLINE INDUSTRIES, INC. 510(k) NO: K052833(ABBREVIATED)
ATTN: JENNIFER MASON PHONE NO : 847-949-2670
ONE MEDLINE PL. SE DECISION MADE: 15-FEB-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
MEDTEK DEVICES, INC. 510(k) NO: K052797(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 800-343-2324
595 COMMERCE DR. SE DECISION MADE: 13-FEB-06
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K052057(TRADITIONAL)
ATTN: SHERRI POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD., N.E. SE DECISION MADE: 17-FEB-06
PO BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073
DEVICE: CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLA
MEDTRONIC INC. 510(k) NO: K060400(TRADITIONAL)
ATTN: DAVID D COX PHONE NO : 763-391-9251
7601 NORTHLAND DRIVE SE DECISION MADE: 28-FEB-06
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BASIS SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K060081(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 13-FEB-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K060203(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 13-FEB-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PBS MODEL 701A COMPRESSION THERAPY DEVICE
MEGO AFEK 510(k) NO: K060220(SPECIAL)
ATTN: AHAVA M STEIN PHONE NO : 972 976 70002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 09-FEB-06
20 HATA'AS ST., 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
MICROGENICS CORP. 510(k) NO: K053411(TRADITIONAL)
ATTN: TONY C LAM PHONE NO : 510-979-5055
46360 FREMONT BLVD. SE DECISION MADE: 03-FEB-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
MIMOSA ACOUSTICS, INC. 510(k) NO: K053216(TRADITIONAL)
ATTN: PATRICIA S JENG PHONE NO : 217-367-9740
60 HAZELWOOD DR., SUITE #209 SE DECISION MADE: 10-FEB-06
CHAMPAIGN, IL 61820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K053361(SPECIAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-254-3565
150 ARAN HILL ROAD SE DECISION MADE: 06-FEB-06
FAIRFIELD, CT 06824-1712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
NIPRO MEDICAL CORPORATION 510(k) NO: K060034(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 28-FEB-06
LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA BRIDGE ALUMINA
NOBEL BIOCARE AB 510(k) NO: K053050(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 22-FEB-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA BRIDGE LAMINATE, MODEL 40-4002
NOBEL BIOCARE AB 510(k) NO: K053068(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 22-FEB-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA BRIDGE ZIRCONIA
NOBEL BIOCARE AB 510(k) NO: K053125(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 22-FEB-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA SOFTWARE, MODEL 33145
NOBEL BIOCARE AB 510(k) NO: K053602(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PARKWAY SE DECISION MADE: 10-FEB-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOGLAS BONE GRAFT PARTICULATE
NOVABONE PRODUCTS, LLC 510(k) NO: K053387(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 14-FEB-06
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
NUVASIVE, INC. 510(k) NO: K053581(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 17-FEB-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMACYN WOUND CARE
OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K060113(TRADITIONAL)
ATTN: TAMMY ATWOOD PHONE NO : 707-283-0550
1129 N. MCDOWELL BLVD. SE DECISION MADE: 22-FEB-06
PETALUMA, CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
ORTHO DEVELOPMENT CORP. 510(k) NO: K053293(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 16-FEB-06
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: DRLOCK DISTAL RADIUS VOLAR SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K053182(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 27-FEB-06
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
OSSACUR AG 510(k) NO: K053374(ABBREVIATED)
ATTN: KRISTI KISTNER PHONE NO : 805-682-8685
975 VERONICS SPRINGS ROAD SE DECISION MADE: 21-FEB-06
SANTA BARBARA, CA 93105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D)
PARAGON VISION SCIENCES 510(k) NO: K052983(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 10-FEB-06
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCRALFATE AND CARAFATE PASTE KITS
PATRICK D. MCGRATH PH.D 510(k) NO: K043587(TRADITIONAL)
ATTN: PATRICK D MCGRATH PHONE NO : 847-543-4138
1471 GREYSTONE DRIVE SE DECISION MADE: 03-FEB-06
GURNEE, IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MOD
PHARMACIA DIAGNOSTICS AB 510(k) NO: K052793(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVENUE SE DECISION MADE: 07-FEB-06
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K060221(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 497 031 4631734
HEWLETT-PACKARD STR.2 SE DECISION MADE: 17-FEB-06
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
PT. MAHAKARYA INTI BUANA 510(k) NO: K053657(TRADITIONAL)
ATTN: P. SASITHARAN NAIR PHONE NO : 626 179 44880
J1. SEI BELUMAI, DESA DALU 10 SE DECISION MADE: 13-FEB-06
A DUSUN I NO. 18, TANJUNG 510(k) SUMMARY AVAILABLE FROM FDA
MORAWA, SUMUT, INDONESIA 20362
DEVICE: EMBRACE WETBOND CLEAR SEALANT
PULPDENT CORPORATION 510(k) NO: K052281(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 08-FEB-06
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOOTHIES GEL PADS
PURONXY, INC. 510(k) NO: K052858(TRADITIONAL)
ATTN: LESLIE SEBASTAIN PHONE NO : 858-228-1660
9853 PACIFIC HEIGHTS BLVD. SE DECISION MADE: 09-FEB-06
SUITE L 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: RADIANCY FACIAL SKINCARE DEVICE
RADIANCY (ISRAEL) LTD. 510(k) NO: K052991(TRADITIONAL)
ATTN: MARGARET FOURTE PHONE NO : 845-398-1647
40 RAMLAND ROAD SE DECISION MADE: 01-FEB-06
SUITE 10 510(k) SUMMARY AVAILABLE FROM FDA
ORANGEBURG, NY 10962
DEVICE: RAVEN PROPACT
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K053212(SPECIAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 15-FEB-06
OMAHA, NE 68127 510(k) STATEMENT
DEVICE: STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K060253(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 23-FEB-06
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S
REGENT MEDICAL AMERICAS, LLC 510(k) NO: K053443(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900
3585 ENGINEERING DR, STE 250 SE DECISION MADE: 01-FEB-06
NORCROSS, GA 30092 510(k) STATEMENT
DEVICE: RES TRAXX DATA CENTER
RESMED LTD. 510(k) NO: K053205(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 03-FEB-06
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTLITE NASAL MASK
RESPIRONICS, INC. 510(k) NO: K053352(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 15-FEB-06
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERATHERM SOS-RESCUE BLANKET
RG ENT., INC. 510(k) NO: K051097(TRADITIONAL)
ATTN: RONALD G LETOURNEAU PHONE NO : 888-596-9498
21130 BRIDGE STREET SE DECISION MADE: 24-FEB-06
SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS ANTI-TG
ROCHE DIAGNOSTICS CORP. 510(k) NO: K053426(SPECIAL)
ATTN: RANDY JOHNSON PHONE NO : 317-521-3532
9115 HAGUE RD. SE DECISION MADE: 07-FEB-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K053603(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 09-FEB-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060108(SPECIAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 16-FEB-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
ROSSMAX INTERNATIONL LTD. 510(k) NO: K053006(TRADITIONAL)
ATTN: YOLANDA LIN PHONE NO : 886 226 597888
12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 03-FEB-06
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA)
SCANTIBODIES LABORATORY, INC. 510(k) NO: K060348(SPECIAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 27-FEB-06
SANTEE, CA 92071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEPH, MODEL 4900
SCHICK TECHNOLOGIES, INC. 510(k) NO: K053558(TRADITIONAL)
ATTN: DANIEL MICHAELI PHONE NO : 718-482-2159
30-00 47TH AVE., FIFTH FLOOR SE DECISION MADE: 17-FEB-06
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLEXISCOPE, MODELS 50MH AND 50 MHC
SCHOELLY IMAGING, INC. 510(k) NO: K053412(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 23-FEB-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE MULTI-PLATFORM SYSTEM
SCITON, INC. 510(k) NO: K060033(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
925 COMMERCIAL ST. SE DECISION MADE: 28-FEB-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEJOY, MODEL MT-403
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K051699(TRADITIONAL)
ATTN: JIANYAO WU PHONE NO : 408-423-8746
1255 SAN TOMAS AQUINO RD. #214 SE DECISION MADE: 06-FEB-06
SAN JOSE, CA 95117 510(k) STATEMENT
DEVICE: SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
SHEFFIELD LABORATORIES, DIV. OF FA510(k) NO: K052162(TRADITIONAL)
ATTN: KATHLEEN HACKU PHONE NO : 860-442-4451
170 BROAD ST. SE DECISION MADE: 06-FEB-06
NEW LONDON, CT 06320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K053523(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 14-FEB-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH 6
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060060(SPECIAL)
ATTN: M. ALAINE MEDIO PHONE NO : 865-218-2703
810 INNOVATION DRIVE SE DECISION MADE: 03-FEB-06
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAY SDX DIGITAL X-RAY SYSTEM
SIGMA BIOMEDICS, INC. 510(k) NO: K060179(TRADITIONAL)
ATTN: KIM ANTOL PHONE NO : 847-419-0669
65 E. PALATINE RD. SE DECISION MADE: 08-FEB-06
#201 510(k) SUMMARY AVAILABLE FROM FDA
PROSPECT HEIGHTS, IL 60070
DEVICE: BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3
SMITH & NEPHEW, INC. 510(k) NO: K053344(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 23-FEB-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVELERT II FLUID LEVEL SENSOR
SMITH & NEPHEW, INC. 510(k) NO: K060123(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 14-FEB-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS DIRECT SL OUTER CATHETER
ST. JUDE MEDICAL 510(k) NO: K053277(TRADITIONAL)
ATTN: DEANNA HUGHES PHONE NO : 818-493-2629
15900 VALLEY VIEW CT. SE DECISION MADE: 24-FEB-06
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NRBC-CHEX FOR LH
STRECK 510(k) NO: K060083(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 09-FEB-06
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBR IDEA CONIC/CONIC
SUDIMPLANT SA 510(k) NO: K050956(ABBREVIATED)
ATTN: DIDIER SAILHAN PHONE NO : 335 621 67100
24 IMPASSE RENE COUZINET- SE DECISION MADE: 16-FEB-06
PARC DE LA PLAINE 510(k) SUMMARY AVAILABLE FROM FDA
TOULOUSE, FRANCE 31500
DEVICE: SUNIPAN IMAGING SYSTEM & ACCESSORIES
SUNI MEDICAL IMAGING, INC. 510(k) NO: K060149(TRADITIONAL)
ATTN: F. A BETTENCOURT PHONE NO : 408-227-6698
6840 VIA DEL ORO, SUITE 160 SE DECISION MADE: 03-FEB-06
SAN JOSE, CA 95119 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
SUNRISE MEDICAL 510(k) NO: K053240(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DRIVE SE DECISION MADE: 03-FEB-06
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPBOND CLEAR WITH TRICLOSAN
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K053565(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE, SUITE 6000 SE DECISION MADE: 03-FEB-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNFIX-LR
SYNTHES SPINE CO.LP 510(k) NO: K053508(TRADITIONAL)
ATTN: ANGELA MIKROULIS PHONE NO : 610-719-5718
1302 WRIGHTS LANE EAST SE DECISION MADE: 13-FEB-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHDEVICE OCCLUSION BALLOON CATHETER
TECHDEVICE CORPORATION 510(k) NO: K051137(TRADITIONAL)
ATTN: LEIGH HAYWARD PHONE NO : 617-972-5808
650 PLEASANT ST. SE DECISION MADE: 24-FEB-06
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
THERATEST LABORATORIES, INC. 510(k) NO: K060176(SPECIAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630-627-6069
1111 N. MAIN ST. SE DECISION MADE: 07-FEB-06
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DE
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K052882(TRADITIONAL)
ATTN: RODRIGO BERLIE PHONE NO : 760-602-2929
3108 AVENIDA OLMEDA SE DECISION MADE: 15-FEB-06
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOOP RECORDER VITAPHONE, 3100 SERIES
TMS TELEMEDIZINISCHE SYSTEME GMBH 510(k) NO: K053378(TRADITIONAL)
ATTN: TILO BORCHARDT PHONE NO : 49 371 400810
STADLERSTRASSE 14 SE DECISION MADE: 23-FEB-06
CHEMNITZ, GERMANY D-09126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AXIOM
TRI DENTAL INNOVATORS 510(k) NO: K051931(TRADITIONAL)
ATTN: LINDA NGUYEN PHONE NO : 714-651-4163
13902 WEST ST., UNIT C SE DECISION MADE: 17-FEB-06
GARDEN GROVE, CA 92843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMED BONE PLATES
TRIMED, INC. 510(k) NO: K060041(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 800-633-7221
25864 TOURNAMENT RD. SUITE A SE DECISION MADE: 07-FEB-06
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROECLIPSE II BREATH ACTUATED NEBULIZER
TRUDELL MEDICAL INTL. 510(k) NO: K053605(SPECIAL)
ATTN: JOHN STRAATMAN PHONE NO : 519 455 7060
725 THIRD ST. SE DECISION MADE: 27-FEB-06
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: NASALGUARD
TRUTEK CORP 510(k) NO: K053625(TRADITIONAL)
ATTN: ASHOK WAHL PHONE NO : 908-685-1111
80 WEST END AVE. SE DECISION MADE: 22-FEB-06
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
TZORA ACTIVE SYSTEMS LTD. 510(k) NO: K052204(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 009 722 9908207
SE DECISION MADE: 15-FEB-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GI DENTSTAT
ULTRADENT PRODUCTS, INC. 510(k) NO: K060334(ABBREVIATED)
ATTN: TAMMY LAVERY PHONE NO : 800-552-5513
505 WEST 10200 SOUTH SE DECISION MADE: 23-FEB-06
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: FILE-EZE
ULTRADENT PRODUCTS, INC. 510(k) NO: K060335(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 800-552-5513
505 WEST 10200 SOUTH SE DECISION MADE: 24-FEB-06
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
VALLEYLAB 510(k) NO: K052796(TRADITIONAL)
ATTN: ROBERT C MOORE PHONE NO : 303-530-6241
5920 LONGBOW DR. SE DECISION MADE: 03-FEB-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K053644(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217
6464 SYCAMORE COURT NORTH SE DECISION MADE: 09-FEB-06
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPA
VASCUTEK LTD. 510(k) NO: K060142(SPECIAL)
ATTN: KAREN KELSO PHONE NO : 44 141 8125555
NEWMAINS AVE. SE DECISION MADE: 07-FEB-06
INCHINNAN INDUSTRIAL ESTATE 510(k) STATEMENT
RENFREWSHIRE, SCOTLAND, UNITED KINGDOM PA4 9RR
DEVICE: MDL SERIES DIODE LASERS, MODEL MDL-10/15
VISION LASERTECHNIK, GMBH 510(k) NO: K042114(TRADITIONAL)
ATTN: ROBERT S HEAD PHONE NO : 801-949-5778
8135 S. BEAUMONT DR. SE DECISION MADE: 03-FEB-06
SANDY, UT 84093 510(k) STATEMENT
DEVICE: JIVE X SOFTWARE
VISUS TECHNOLOGY TRANSFER GMBH 510(k) NO: K053183(TRADITIONAL)
ATTN: STEPHEN NEUSHUL PHONE NO : 310-921-9559
20406 EARL STREET SE DECISION MADE: 16-FEB-06
TORRANCE, CA 90503 510(k) STATEMENT
DEVICE: X-TRA FIL
VOCO GMBH 510(k) NO: K053391(ABBREVIATED)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 15-FEB-06
CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALUX IRIS EXAMINATION AND SURGICAL LAMP
WALDMANN LIGHTING 510(k) NO: K053364(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 23-FEB-06
DEERFIELD, IL 6015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAVELIGHT IDAS
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K053604(TRADITIONAL)
ATTN: THORSTEN CRETER PHONE NO : 001 496 102369225
FRANKFURTER STRASSE 229 SE DECISION MADE: 22-FEB-06
NEU-ISENBURG, HESSEN, GERMANY 6326510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
WENZHOU WUZHOU GROUP CO. LTD. 510(k) NO: K060211(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748
1800 CENTURY PARK EAST SE DECISION MADE: 10-FEB-06
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90067 THIRD PARTY REVIEW
DEVICE: I-D GLIDE
WESTRIDGE LABORATORIES INC. 510(k) NO: K051295(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 15-FEB-06
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WWMED, MODEL 401
WONG WAY CORPORATION 510(k) NO: K051961(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 10-FEB-06
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIIG SR
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060011(TRADITIONAL)
ATTN: BRIAN J YOUNG PHONE NO : 901-867-4120
5677 AIRLINE RD. SE DECISION MADE: 27-FEB-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VACLOK SYRINGE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060095(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 10-FEB-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO, MODEL V6.0
ZIMMER ELEKTROMEDIZIN GMBH 510(k) NO: K060395(SPECIAL)
ATTN: ARMIN PETRASCHKA PHONE NO : 490 731 97610
JUNKERSSTRASSE 9 SE DECISION MADE: 24-FEB-06
NEU-ULM, GERMANY 89231 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
ZIMMER TRABECULAR 510(k) NO: K053340(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 27-FEB-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYS EPOCH FULLCOAT HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K052321(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 15-FEB-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 220
TOTAL WITH SUMMARIES 197
TOTAL WITH STATEMENTS 23
Updated Month 06, 2006
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