-
Medical Devices
-
March 2006 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAR-2006 THROUGH 31-MAR-2006
DEVICE: A.B. DENTAL DEVICES
A.B. DENTAL DEVICES, LTD. 510(k) NO: K051719(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9940337
MITZPE AVIV SE DECISION MADE: 21-MAR-06
INDUSTRIAL PARK 13 510(k) STATEMENT
M.P. MISGAV, ISRAEL 20187
DEVICE: FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
ABBOTT DIABETES CARE INC. 510(k) NO: K051839(TRADITIONAL)
ATTN: DHRUMA SHAH PHONE NO : 510-749-6475
1360 SOUTH LOOP RD. SE DECISION MADE: 09-MAR-06
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
ABBOTT SPINE, INC. 510(k) NO: K060009(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 06-MAR-06
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 72
ABBOTT SPINE, INC. 510(k) NO: K060634(TRADITIONAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 31-MAR-06
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
ACMI CORPORATION 510(k) NO: K060269(TRADITIONAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739
136 TURNPIKE RD. SE DECISION MADE: 31-MAR-06
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMO
ACON LABORATORIES, INC. 510(k) NO: K060173(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-MAR-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUIPMENT SLUSH DRAPE
ADVANCE MEDICAL DESIGNS, INC. 510(k) NO: K053495(TRADITIONAL)
ATTN: WILLIAM SLEVIN PHONE NO : 770-422-3125
1241 ATLANTA INDUSTRIAL DR. SE DECISION MADE: 16-MAR-06
MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
AEROVECTRX CORPORATION 510(k) NO: K053360(TRADITIONAL)
ATTN: DAVE PIPER PHONE NO : 916-834-3283
6224 SAMOA WAY SE DECISION MADE: 23-MAR-06
CARMICHAEL, CA 95608 510(k) STATEMENT
DEVICE: EXCIA TOTAL HIP SYSTEM WITH U-CAP
AESCULAP, INC. 510(k) NO: K060437(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 22-MAR-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL S
AESCULAP, INC. 510(k) NO: K060528(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 28-MAR-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY 3-10 MIN FLASH INTEGRATOR
ALBERT BROWNE LTD. 510(k) NO: K060066(TRADITIONAL)
ATTN: CYNTHIA J M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 24-MAR-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
ALBERT BROWNE LTD. 510(k) NO: K060103(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 07-MAR-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
ALVEOLUS, INC. 510(k) NO: K060239(TRADITIONAL)
ATTN: DON CANAL PHONE NO : 704-926-4837
9013 PERIMETER WOODS SUITE A SE DECISION MADE: 22-MAR-06
CHARLOTTE, NC 28216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K060023(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 09-MAR-06
QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYSET PREGNANCY TEST
ANI BIOTECH OY 510(k) NO: K053138(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 01-MAR-06
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO IR HEAT LAMP SYSTEM
APOLLO PHYSICAL THERAPY PRODUCTS I510(k) NO: K060134(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD. SE DECISION MADE: 21-MAR-06
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77047
DEVICE: INTUITIVE SURGICAL SEAL
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K060534(SPECIAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 13-MAR-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PEDIATRIC URETERAL STENT
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K060673(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 29-MAR-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
ARIZANT HEALTHCARE INC. 510(k) NO: K053645(SPECIAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277
10393 WEST 70TH ST. SE DECISION MADE: 09-MAR-06
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
ARKRAY, INC. 510(k) NO: K053401(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 24-MAR-06
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: ATHROCARE TOPAZ ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K053567(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 06-MAR-06
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
ARTHROSURFACE, INC. 510(k) NO: K060127(TRADITIONAL)
ATTN: STEVEN W EK PHONE NO : 508-520-3003
28 FORGE PARKWAY SE DECISION MADE: 16-MAR-06
FRANKLIN, MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISTAR
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K060455(SPECIAL)
ATTN: REINHARD THIEME PHONE NO : +49 364 1220211
GOESCHWITZERSTRASSE 51-52 SE DECISION MADE: 20-MAR-06
JENA, GERMANY 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADROSTAR 532
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K060457(SPECIAL)
ATTN: REINHARD THIEME PHONE NO : +49 364 1220211
GOESCHWITZERSTRASSE 51-52 SE DECISION MADE: 20-MAR-06
JENA, GERMANY 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADROSTAR 980
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K060459(SPECIAL)
ATTN: REINHARD THIEME PHONE NO : +49 364 1220211
GOESCHWITZERSTRASSE 51-52 SE DECISION MADE: 20-MAR-06
JENA, GERMANY 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH I
ASTRA TECH, INC. 510(k) NO: K053384(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 24-MAR-06
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
ATLANTIS COMPONENTS, INC. 510(k) NO: K053450(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 03-MAR-06
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM MEDICAL CORPORATION C-QUR MESH
ATRIUM MEDICAL CORP. 510(k) NO: K050311(TRADITIONAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 31-MAR-06
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM FLIXENE GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K060124(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 30-MAR-06
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZE VIRTUALPLACE
AZE, LTD. 510(k) NO: K060453(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8080
5353 WAYZATA BLVD. SE DECISION MADE: 09-MAR-06
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416-1334 THIRD PARTY REVIEW
DEVICE: BTI INTERNA DENTAL IMPLANT SYSTEM
B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K053355(SPECIAL)
ATTN: ALFREDO GOMEZ MENGOD PHONE NO : 349 452 97030
PARQUE TECNOLOGICO DE ALAVA SE DECISION MADE: 14-MAR-06
LEONARDO DA VINCI 14B 510(k) SUMMARY AVAILABLE FROM FDA
MINANO(ALAVA), SPAIN 01510
DEVICE: VOXAR 3D ENTERPRISE, MODEL 6.1
BARCOVIEW MIS EDINBURGH 510(k) NO: K060505(SPECIAL)
ATTN: NEIL PHILLIPS PHONE NO : 013 147 24792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 29-MAR-06
EDINBURGH, UNITED KINGDOM EH6 5NP 510(k) STATEMENT
DEVICE: INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
BAXTER HEALTHCARE CORP. 510(k) NO: K060074(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
1620 WAUKEGAN RD SE DECISION MADE: 29-MAR-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF TUNNELER WIRE
BAYLIS MEDICAL CO., INC. 510(k) NO: K051670(TRADITIONAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875
2580 MATHESON BLVD. E SE DECISION MADE: 30-MAR-06
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER 5C CELL CONTROL
BECKMAN COULTER, INC. 510(k) NO: K060464(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 28-MAR-06
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD AUTOSHIELD PEN NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K060007(TRADITIONAL)
ATTN: JAMES W HAYNES PHONE NO : 201-847-4298
1 BECTON DR. SE DECISION MADE: 23-MAR-06
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16
BECTON, DICKINSON & CO. 510(k) NO: K060214(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 09-MAR-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8
BECTON, DICKINSON & CO. 510(k) NO: K060218(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 17-MAR-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTI
BECTON, DICKINSON & CO. 510(k) NO: K060493(TRADITIONAL)
ATTN: MONICA E GUIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 29-MAR-06
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTHSHAPES
BICELLULASE, INC. 510(k) NO: K053611(TRADITIONAL)
ATTN: ROBERT NAGEL PHONE NO : 617-733-7077
21 PARK AVE. SE DECISION MADE: 15-MAR-06
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONEGEN - TR
BIO-LOK INTL., INC. 510(k) NO: K060285(TRADITIONAL)
ATTN: HAROLD ALEXANDER PHONE NO : 973-467-2404
505 MORRIS AVENUE, SUITE 104 SE DECISION MADE: 16-MAR-06
SPRINGFIELD, NJ 07081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
BIODYNAMICS CORP. 510(k) NO: K051675(TRADITIONAL)
ATTN: EDWARD M RIFKIN PHONE NO : 206-526-0205
4554 9TH AVENUE NE, #100 SE DECISION MADE: 16-MAR-06
SEATTLE, WA 98105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIDIS VASCULITIS, MODEL MX007
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K053012(TRADITIONAL)
ATTN: CHRISTELLE COURIVAUD PHONE NO : 330 164 621012
ACTIPOLE 25 SE DECISION MADE: 02-MAR-06
4-6 BLD DE BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: FIDIS CELIAC
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K053383(TRADITIONAL)
ATTN: COURIVAUD CHRISTELLE PHONE NO : 33 1 64621012
ACTIPOLE 25 SE DECISION MADE: 29-MAR-06
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: FIDIS CONNECTIVE 10, MODEL MX006
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K053653(TRADITIONAL)
ATTN: CHRISTELLE COURIVAUD PHONE NO : 331 646 21012
ACTIPOLE 25 SE DECISION MADE: 13-MAR-06
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUME
BIOMET MANUFACTURING CORP. 510(k) NO: K060121(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
56 EAST BELL DRIVE SE DECISION MADE: 21-MAR-06
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
BIOMET MANUFACTURING CORP. 510(k) NO: K060303(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 30-MAR-06
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
BIOPTIK TECHNOLOGY, INC. 510(k) NO: K053312(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 214-243-8218
6833 ST. LAWRENCE STREET SE DECISION MADE: 01-MAR-06
PLANO, TX 75024 510(k) STATEMENT
DEVICE: NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
BIOSENSE WEBSTER, INC. 510(k) NO: K053194(TRADITIONAL)
ATTN: SIGI CARON PHONE NO : 310-377-3069
2400 VIA CARRILLO SE DECISION MADE: 09-MAR-06
PALOS VERDES ESTATES, CA 90274 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER,
BIOTEX, INC. 510(k) NO: K053087(TRADITIONAL)
ATTN: ASHOK GOWDA PHONE NO : 713-741-0111
8058 EL RIO ST. SE DECISION MADE: 01-MAR-06
HOUSTON, TX 77054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
BIOTEX, INC. 510(k) NO: K060304(TRADITIONAL)
ATTN: MATTHEW FOX PHONE NO : 713-741-0111
8058 EL RIO ST. SE DECISION MADE: 21-MAR-06
HOUSTON, TX 77054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISCO LED
BISCO, INC. 510(k) NO: K052122(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 29-MAR-06
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
BOEHRINGER LABORATORIES 510(k) NO: K060277(TRADITIONAL)
ATTN: CHRISTOPHER RADL PHONE NO : 610-278-0900
500 E. WASHINGTON ST. SE DECISION MADE: 03-MAR-06
NORRISTOWN, PA 19401 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PVS 2000 SYNCHRO2 GUIDEWIRE
BOSTON SCIENTIFIC - PRECISION VASC510(k) NO: K053268(SPECIAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736
2405 WEST ORTON CIR. SE DECISION MADE: 13-MAR-06
WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISIGHT IMAGING CATHETER, MODEL 38986
BOSTON SCIENTIFIC CORP. 510(k) NO: K060175(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 24-MAR-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCERTO BIPOLAR NEEDLE ELECTRODE
BOSTON SCIENTIFIC CORP. 510(k) NO: K060419(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-683-4003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 13-MAR-06
NATICK, MA 01760-1573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060572(SPECIAL)
ATTN: ELAINE APLAON PHONE NO : 408-866-3204
160 KNOWLES DR. SE DECISION MADE: 15-MAR-06
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN FLOW
BRAINLAB AG 510(k) NO: K053164(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 23-MAR-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION HIP
BRAINLAB AG 510(k) NO: K060468(SPECIAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 20-MAR-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-ARM IMAGING SYSTEM
BREAKAWAY IMAGING, LLC 510(k) NO: K060344(TRADITIONAL)
ATTN: RICK GRANT PHONE NO : 978-339-6426
300 FOSTER STREET SE DECISION MADE: 29-MAR-06
LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAS VIVO 40 SYSTEM
BREAS MEDICAL AB 510(k) NO: K053607(TRADITIONAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 011 46 31868800
FORETAGSVAGEN 1 SE DECISION MADE: 16-MAR-06
MOLNLYCKE, SWEDEN SE-435 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQMARK EZ STRESS
BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K052898(TRADITIONAL)
ATTN: RUOMEI ZHANG PHONE NO : 310-257-7210
3300 FUJITA ST. SE DECISION MADE: 28-MAR-06
TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIGITAL RADIOGRAPHY CXDI-50C
CANON INC. 510(k) NO: K060433(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 10-MAR-06
LAKE SUCCESS, NY 11042 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMMOCARE
CARE DIAGNOSTIC, INC. 510(k) NO: K052598(TRADITIONAL)
ATTN: ARACELI FANCHER-FERREIRA PHONE NO : 541-850-9402
1741 WIARD STREET SE DECISION MADE: 16-MAR-06
KLAMATH FALLS, OR 97603 510(k) STATEMENT
DEVICE: ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR
CLINICAL MICRO SENSORS, INC. 510(k) NO: K060543(SPECIAL)
ATTN: WILLIAM COTY PHONE NO : 626-463-2000
757 SOUTH RAYMOND AVE. SE DECISION MADE: 28-MAR-06
PASADENA, CA 91105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINI
CLINIQA CORPORATION 510(k) NO: K060322(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432-B SOUTH MISSION RD. SE DECISION MADE: 21-MAR-06
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS
CLINTON ELECTRONICS CORP. 510(k) NO: K053039(TRADITIONAL)
ATTN: RANDALL J SCHROEDL PHONE NO : 815-633-1444
6701 CLINTON ROAD SE DECISION MADE: 01-MAR-06
LOVES PARK, IL 61111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HO
CODONICS, INC. 510(k) NO: K060440(SPECIAL)
ATTN: ALAN DESANTIS PHONE NO : 440-243-1198
17991 ENGLEWOOD DR. SE DECISION MADE: 16-MAR-06
MIDDLEBURG HEIGHTS, OH 44130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS BREAST COIL 4/SMS
CONFIRMA, INC. 510(k) NO: K060547(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733
821 KIRKLAND AVE. SE DECISION MADE: 29-MAR-06
KIRKLAND, WA 98033-6318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
CONFORMIS, INC. 510(k) NO: K053488(TRADITIONAL)
ATTN: PATRICK HESS PHONE NO : 650-286-4166
323 VINTAGE PARK DR. SE DECISION MADE: 09-MAR-06
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
FOSTER CITY, CA 94404
DEVICE: MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
COOK INCORPORATED 510(k) NO: K060224(SPECIAL)
ATTN: THALIA BRINE PHONE NO : 812-339-2235
750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 06-MAR-06
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
CYBERKINETICS, INC. 510(k) NO: K060523(SPECIAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 28-MAR-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDXNET
CYBERMDX, INC. 510(k) NO: K060035(ABBREVIATED)
ATTN: JOHN COLEMAN PHONE NO : 401-274-5633
RICHMOND SQUARE SE DECISION MADE: 09-MAR-06
SUITE 166W 510(k) SUMMARY AVAILABLE FROM FDA
PROVIDENCE, RI 02906
DEVICE: CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
D.F.I. CO LTD 510(k) NO: K052525(TRADITIONAL)
ATTN: ASAD R ZAIDI PHONE NO : 949-660-7770
2815 MCGAW AVENUE SE DECISION MADE: 29-MAR-06
IRVINE, CA 92614 510(k) STATEMENT
DEVICE: N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
DADE BEHRING, INC. 510(k) NO: K052788(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 29-MAR-06
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
DADE BEHRING, INC. 510(k) NO: K053072(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 28-MAR-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
DADE BEHRING, INC. 510(k) NO: K053073(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 28-MAR-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN CERULOPLASMIN
DADE BEHRING, INC. 510(k) NO: K053074(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 16-MAR-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN TRANSFERRIN
DADE BEHRING, INC. 510(k) NO: K053075(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 16-MAR-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1
DADE BEHRING, INC. 510(k) NO: K053531(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 03-MAR-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
DADE BEHRING, INC. 510(k) NO: K060264(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 08-MAR-06
GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK,, DE 19714
DEVICE: DIMENSION IRON CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K060266(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 09-MAR-06
GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK,, DE 19714
DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VAN
DADE BEHRING, INC. 510(k) NO: K060312(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO :
2040 ENTERPRISE BLVD. SE DECISION MADE: 23-MAR-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE EMIT 2000 TACROLIMUS CALIBRATORS
DADE BEHRING, INC. 510(k) NO: K060371(TRADITIONAL)
ATTN: UK-TING LEWIS PHONE NO : 302-631-7626
PO BOX 6101 SE DECISION MADE: 09-MAR-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI C
DADE BEHRING, INC. 510(k) NO: K060628(SPECIAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 22-MAR-06
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DP240 240 HOUR DOPPLER PROBE
DELTEX MEDICAL 510(k) NO: K052989(TRADITIONAL)
ATTN: LAWRENCE BROOKFIELD PHONE NO : 011 44 1243523174
TERMINUS RD. SE DECISION MADE: 08-MAR-06
CHICHESTER, WEST SUSSEX, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FENIIIIIIX COLORATION KIT
DENTAL ARTE, INC. 510(k) NO: K060086(TRADITIONAL)
ATTN: MASSIMO SASSO PHONE NO : 858-486-5484
12315 OAK KNOLL ROAD SE DECISION MADE: 03-MAR-06
SUITE 330 510(k) SUMMARY AVAILABLE FROM FDA
POWAY, CA 92064-5343
DEVICE: DOCTOR'S NIGHTGUARD
DENTAL CONCEPTS LLC. 510(k) NO: K053580(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW SE DECISION MADE: 03-MAR-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPROXIMAL REDUCTION SYSTEM
DENTSPLY INTERNATIONAL 510(k) NO: K053368(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. SE DECISION MADE: 29-MAR-06
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: AGILITY LP TOTAL ANKLE PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K053569(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 31-MAR-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PFC SIGMA KNEE PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060515(SPECIAL)
ATTN: STEVEN J WENTWORTH PHONE NO : 574-371-4913
700 ORTHOPAEDIC DR. SE DECISION MADE: 23-MAR-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MISSION COMPLETE
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K060206(TRADITIONAL)
ATTN: RANDOLPH QUINN PHONE NO : 508-429-0450
333 FISKE ST. SE DECISION MADE: 21-MAR-06
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETI-MAX 3000
DIASORIN, INC. 510(k) NO: K052794(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850
1951 NORTHWESTERN AVE. SE DECISION MADE: 31-MAR-06
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: MIGUE
DIREX SYSTEMS CORP. 510(k) NO: K052212(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837
437 TURNPIKE ST. SE DECISION MADE: 10-MAR-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA
DIREX SYSTEMS CORP. 510(k) NO: K053640(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013
437 TURNPIKE ST. SE DECISION MADE: 01-MAR-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANSE S+ ULTRASONIC SCALER
DMETEC CO., LTD. 510(k) NO: K060171(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-MAR-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVISIONAL INLAY/ONLAY KIT
DMG USA, INC. 510(k) NO: K052800(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 07-MAR-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGBODY DT-600
DURTECH SYSTEM CORP. 510(k) NO: K053284(TRADITIONAL)
ATTN: ADA LIN PHONE NO : 886 226 946022
3F, NO. 27, LANE 381 SE DECISION MADE: 10-MAR-06
FU-THE 1ST ROAD 510(k) STATEMENT
HIS-CHIH TAIPEI, CHINA (TAIWAN) 22THIRD PARTY REVIEW
DEVICE: E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE
E SURGICAL, LLC 510(k) NO: K060255(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 31-MAR-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
EASTMAN KODAK COMPANY 510(k) NO: K060137(SPECIAL)
ATTN: LINDA STEWART PHONE NO : 972-805-4167
343 STATE ST. SE DECISION MADE: 16-MAR-06
ROCHESTER, NY 14650 510(k) STATEMENT
DEVICE: KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 655
EASTMAN KODAK COMPANY 510(k) NO: K060550(SPECIAL)
ATTN: CHRISTINE E EHMANN PHONE NO : 585-724-4487
343 STATE ST. SE DECISION MADE: 31-MAR-06
ROCHESTER, NY 14650-1131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI VERTEBROPLASTY SYSTEMS
EBI, L.P. 510(k) NO: K060148(TRADITIONAL)
ATTN: BARRY E SANDS PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 13-MAR-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ANTERIOR CERVICAL PLATE SYSTEM
EBI, L.P. 510(k) NO: K060379(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 06-MAR-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K060487(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416
ONE EDWARDS WAY SE DECISION MADE: 23-MAR-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LYSUS INFUSION SYSTEM
EKOS CORP. 510(k) NO: K060422(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 09-MAR-06
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: ELITE ELECTROMED L.I.T.E. 4/1
ELITE ELECTROMEDICAL 510(k) NO: K053507(TRADITIONAL)
ATTN: GARY HUDDLESTON PHONE NO : 573-348-5982
4960 WILSON DR. SE DECISION MADE: 15-MAR-06
OSAGE BEACH, MO 65065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDIN
ELLEX MEDICAL PTY. LTD. 510(k) NO: K052777(TRADITIONAL)
ATTN: KEVIN HOWARD PHONE NO : 618 810 45200
82 GILBERT ST. SE DECISION MADE: 16-MAR-06
ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT
DEVICE: EMD THERMOGRAPHY SYSTEM
EM DIAGNOSTICS, INC. 510(k) NO: K050239(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 16-MAR-06
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
ENERGIST, LTD. 510(k) NO: K060216(TRADITIONAL)
ATTN: PETER SMITH PHONE NO : 44 179 2798768
2 CLOS LLYN CWM SE DECISION MADE: 16-MAR-06
ENTERPRISE PARK 510(k) SUMMARY AVAILABLE FROM FDA
SWANSEA, UNITED KINGDOM SA6 8QY
DEVICE: ERBE VIO ESU, MODEL VIO 300 D
ERBE USA, INC. 510(k) NO: K060484(SPECIAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 16-MAR-06
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVANCE* FACIAL REJUVENATION SYSTEM
ETHICON, INC. 510(k) NO: K052953(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 908-218-3323
RT. 22 WEST SE DECISION MADE: 06-MAR-06
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: SEMPERFLO INFUSION SYSTEM
ETHICON, INC. 510(k) NO: K052999(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 908-218-3323
RT. 22 WEST SE DECISION MADE: 22-MAR-06
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002
EUROTROL B.V. 510(k) NO: K060215(TRADITIONAL)
ATTN: ALLAN WHITE PHONE NO : 800-881-1611
40 EMPIRE DRIVE SE DECISION MADE: 24-MAR-06
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
EV3 INC. 510(k) NO: K060057(SPECIAL)
ATTN: MELISSA SOMMERFELD PHONE NO : 763-398-7612
4600 NATHAN LN. NORTH SE DECISION MADE: 08-MAR-06
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYEPORT VISION TRAINING SYSTEM
EXERCISE YOUR EYES, INC. 510(k) NO: K051684(TRADITIONAL)
ATTN: JACOB LIBERMAN PHONE NO : 808-876-1926
133 KA DRIVE SE DECISION MADE: 17-MAR-06
KULA, HI 96790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
FERTI PRO N.V. 510(k) NO: K053494(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO SE DECISION MADE: 23-MAR-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBER-METAL POST
FOREMOST DENTAL LLC. 510(k) NO: K060075(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 30-MAR-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT PERFUSION 4
GE HEALTHCARE 510(k) NO: K052839(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD W 1140 SE DECISION MADE: 10-MAR-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VIX WIN PRO
GENDEX DENTAL SYSTEMS 510(k) NO: K060178(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 10-MAR-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
GENERAL ELECTRIC CO. 510(k) NO: K060542(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
4855 WESTELECTRIC AVENUE SE DECISION MADE: 31-MAR-06
PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53219
DEVICE: AIM ACCURACY IN MARKING SYSTEM
GEORGENE AUSTRIA 510(k) NO: K053463(TRADITIONAL)
ATTN: GEORGENE AUSTRIA PHONE NO : 818-635-8907
5755 VALERIE AVENUE SE DECISION MADE: 07-MAR-06
WOODLAND HILLS, CA 91367 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMATIK CLINICAL ZIRCONIA
GLIDEWELL LABORATORIES 510(k) NO: K060104(TRADITIONAL)
ATTN: KEITH D ALLRED PHONE NO : 949-440-2683
4141 MACARTHUR BLVD. SE DECISION MADE: 15-MAR-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSS PEDICLE SCREW SYSTEM
GS MEDICAL CO., LTD. 510(k) NO: K053573(TRADITIONAL)
ATTN: SUN-EUN JUNG PHONE NO : 82 2 8601455
222-13 GURO-DONG, GURO-GU SE DECISION MADE: 08-MAR-06
ROOM NO. 703 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 152-848
DEVICE: ACUITY STEERABLE STYLET ACCESSORY
GUIDANT CORPORATION 510(k) NO: K053019(TRADITIONAL)
ATTN: JENNIFER X TANG PHONE NO : 651-582-6746
4100 HAMLINE AVE NORTH SE DECISION MADE: 03-MAR-06
ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX HERCULINK ELITE BILIARY STENT SYSTEM
GUIDANT CORPORATION 510(k) NO: K053454(TRADITIONAL)
ATTN: KEITH KROHN PHONE NO : 951-914-6513
3200 LAKESIDE DRIVE SE DECISION MADE: 06-MAR-06
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAPHYSEAL PLATE
HAND INNOVATIONS, LLC. 510(k) NO: K060294(TRADITIONAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899
8905 SW 87TH AVENUE, SE DECISION MADE: 22-MAR-06
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI LAKES, FL 33176
DEVICE: HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
HAWKEN INDUSTRIES 510(k) NO: K052891(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 23-MAR-06
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBEAT
HITACHI, LTD., POWER SYSTEMS GROUP510(k) NO: K053280(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 09-MAR-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAP
HOWMEDICA OSTEONICS CORP 510(k) NO: K060360(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 15-MAR-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PLATING SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K060514(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 17-MAR-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSINER RESUSCITATOR
HSINER CO., LTD. 510(k) NO: K053466(ABBREVIATED)
ATTN: TOM SHANKS PHONE NO : 951-506-2674
29201 VIA NORTE SE DECISION MADE: 22-MAR-06
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOPPLEX CENTRALE
HUNTLEIGH HEALTHCARE LTD. 510(k) NO: K060230(TRADITIONAL)
ATTN: HUW JONES PHONE NO : 44 292 0485885
35 PORTMANMOOR RD. SE DECISION MADE: 23-MAR-06
CARDIFF, SOUTH GLAMORGAN, UNITED K510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
HYPOGUARD USA, INC. 510(k) NO: K053079(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 28-MAR-06
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K060156(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858
3150 E. 200TH ST. SE DECISION MADE: 20-MAR-06
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP
IDEAL LIFE INC. 510(k) NO: K060504(TRADITIONAL)
ATTN: DIANE MANDELL PHONE NO : 202-730-4130
1220 19TH STREET N.W. SE DECISION MADE: 14-MAR-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036 THIRD PARTY REVIEW
DEVICE: CELLTRACKS ANALYZER II
IMMUNICON CORP. 510(k) NO: K060110(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 215-346-8251
3401 MASONS MILL RD. STE 100 SE DECISION MADE: 16-MAR-06
HUNTINGDON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING
IMPLANT LOGIC SYSTEMS, LTD. 510(k) NO: K060267(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 17-MAR-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUREX GLUCOSE TEST STRIP
INCLINE MEDICAL, LLC 510(k) NO: K052207(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 09-MAR-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION HEXALON BIODEGRADABLE ACL/PCL SCREW
INION LTD. 510(k) NO: K060393(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 13-MAR-06
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACULIFE, MODEL SMW-01
INNO-HEALTH TECHNOLOGY, INC. 510(k) NO: K051197(TRADITIONAL)
ATTN: TERRY C CHIANG PHONE NO : 886 4 23270788
8F-2, NO. 61 KUNG-YI ROAD SE DECISION MADE: 28-MAR-06
SECTION 2 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 408
DEVICE: INNOCURE IMRT FILTER (COMPENSATORS)
INNOCURE, LLC 510(k) NO: K052383(TRADITIONAL)
ATTN: DONALD W COLLINS PHONE NO : 480-829-0479
201 E. SOUTHERN AVE. SE DECISION MADE: 29-MAR-06
SUITES 201 & 202 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85282-5133
DEVICE: INNOCOR
INNOVISION A/S 510(k) NO: K051907(TRADITIONAL)
ATTN: RICHARD O WOOD PHONE NO : 312-807-4364
70 W. MADISON ST., STE 3300 SE DECISION MADE: 02-MAR-06
CHICAGO, IL 60602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRSTAR IS02 MICROCURRENT STIMULATOR
INSPIRSTAR, INC. 510(k) NO: K060368(TRADITIONAL)
ATTN: NING WU PHONE NO : 480-282-1059
891 N. NAPLES DR. SE DECISION MADE: 14-MAR-06
CHANDLER, AZ 85226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
INVACARE CORPORATION 510(k) NO: K060582(SPECIAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 16-MAR-06
ELYRIA, OH 44035-4190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
IOMED, INC. 510(k) NO: K060236(TRADITIONAL)
ATTN: CURTIS JENSEN PHONE NO : 801-975-1191
2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 31-MAR-06
SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISIS OCULAR GRAFT
IOP, INC. 510(k) NO: K053622(TRADITIONAL)
ATTN: JASON MALECKA PHONE NO : 714-549-1185
3184 AIRWAY AVE., BLDG. B SE DECISION MADE: 15-MAR-06
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQUIRY AFOCUS II DIAGNOSTIC CATHETER
IRVINE BIOMEDICAL, INC. 510(k) NO: K053582(SPECIAL)
ATTN: ELVIA ZAVALA PHONE NO : 949-851-3053
2375 MORSE AVE. SE DECISION MADE: 21-MAR-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
ISOTIS NV 510(k) NO: K060306(TRADITIONAL)
ATTN: ELIANE SCHUTTE PHONE NO : 949-595-8710
2 GOODYEAR, SUITE B SE DECISION MADE: 27-MAR-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
ISOTIS NV 510(k) NO: K060332(TRADITIONAL)
ATTN: ELIANE SCHUTTE PHONE NO : 310 30 2995253
PROF. BRONKHORSTLAAN 10-D SE DECISION MADE: 29-MAR-06
BILTHOVEN, NETHERLANDS 3723 MB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKCAT EXTRACTION CATHETER
KENSEY NASH CORP. 510(k) NO: K060092(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 484-713-2100
735 PENNSYLVANIA AVE. SE DECISION MADE: 09-MAR-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK MODELS 2100 AND 2200
KODAK-TROPHY 510(k) NO: K060292(SPECIAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 33 164 808500
4 RUE FERDINAND PELLOUTIER SE DECISION MADE: 03-MAR-06
CROISSY-BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77 437
DEVICE: TITAN GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K060454(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 24-MAR-06
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVANTICARE, MODEL SA4021
LERADO CHINA LIMITED 510(k) NO: K060068(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 4 22465396
CHONGDE RD., BEITUN DISTRICT SE DECISION MADE: 08-MAR-06
TAICHUNG, CHINA (TAIWAN) 40653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
LIBERTY HEALTHCARE GROUP, INC. 510(k) NO: K060426(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 09-MAR-06
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY GLUCOSE CONTROL SOLUTION
LIBERTY HEALTHCARE GROUP, INC. 510(k) NO: K060481(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 09-MAR-06
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,C
LIFE-SHIELD PRODUCTS, INC 510(k) NO: K060208(SPECIAL)
ATTN: CHAO-HUA SHIH PHONE NO : 886 222 996033
3F, NO 10, WUCHIUAN 7TH RD SE DECISION MADE: 10-MAR-06
WUGU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 248
DEVICE: ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, C
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K050945(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 29-MAR-06
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K051058(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 29-MAR-06
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IR WIRELESS FOOT SWITCH
LINEMASTER SWITCH CORP. 510(k) NO: K053510(TRADITIONAL)
ATTN: MIKE SZOSTEK PHONE NO : 860-974-1000
29 PLAINE HILL ROAD SE DECISION MADE: 20-MAR-06
WOODSTOCK, CT 06281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA
LUMENIS, INC. 510(k) NO: K060338(SPECIAL)
ATTN: CONNIE HOY PHONE NO : 408-764-3303
2400 CONDENSA ST. SE DECISION MADE: 09-MAR-06
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
MANI, INC. 510(k) NO: K053636(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301K STREET, N.W. SE DECISION MADE: 14-MAR-06
SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-3373
DEVICE: SYVEKEXCEL
MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K053300(TRADITIONAL)
ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781-270-3200
107 WATER ST. SE DECISION MADE: 28-MAR-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
MASIMO CORPORATION 510(k) NO: K053477(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 16-MAR-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
MCCUE PLC 510(k) NO: K060234(TRADITIONAL)
ATTN: STEVEN PEACH PHONE NO : 44 148 9795668
SOLENT INDUSTRIAL ESTATE SE DECISION MADE: 15-MAR-06
HEDGE END. 510(k) SUMMARY AVAILABLE FROM FDA
SOUTHAMPTON, HAMPSHIRE, UNITED KINGDOM SO30-2FY
DEVICE: THERATRON EQUINOX, MODELS 80 CM AND 100 CM
MDS NORDION INC. 510(k) NO: K053485(SPECIAL)
ATTN: ROSS KACHANIWSKY PHONE NO : 613 592 3400
447 MARCH ROAD SE DECISION MADE: 09-MAR-06
OTTAWA, ONTARIO, CANADA K2K 1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PD CATH
MED-CONDUIT, INC. 510(k) NO: K053123(TRADITIONAL)
ATTN: GERALD G BOUSQUET PHONE NO : 978-649-2640
18 DERBY LANE SE DECISION MADE: 29-MAR-06
TYNGSBORO, MA 01879 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
MEDCOMP 510(k) NO: K053345(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 17-MAR-06
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVECARE ++ SYSTEM
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K060146(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 3 6123281
7 JABOTINSKY STREET SE DECISION MADE: 08-MAR-06
MOSHE AVIV TOWER 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT GAN, ISRAEL 52520
DEVICE: MAXILIM
MEDICIM NV 510(k) NO: K052424(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 31-MAR-06
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS
MEDITECH INTERNATIONAL, INC. 510(k) NO: K051875(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE ST. SE DECISION MADE: 13-MAR-06
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD 3.0T ECOIL IMAGING SYSTEM
MEDRAD, INC. 510(k) NO: K060401(SPECIAL)
ATTN: LISA A EWING PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 15-MAR-06
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN SELECT II 624DEL DELIVERY CATHETER SYSTEM
MEDTRONIC IRELAND 510(k) NO: K053431(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-505-7863
1015 GRAMSIE ROAD SE DECISION MADE: 16-MAR-06
SHOREVIEW, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
MEDTRONIC NAVIGATION, INC. 510(k) NO: K052623(SPECIAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217
826 COAL CREEK CIRCLE SE DECISION MADE: 02-MAR-06
LOUSVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
MEDTRONIC XOMED, INC. 510(k) NO: K053430(TRADITIONAL)
ATTN: PENNY LAYMAN PHONE NO : 904-332-8959
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 03-MAR-06
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8F SHERPA NX GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K060418(SPECIAL)
ATTN: MARK PUOPOLO PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 15-MAR-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K053335(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 10-MAR-06
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA (PROGRESSIVE TIBIAL ALIGNMENT)
MERIDIAN MEDICAL 510(k) NO: K060403(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 28-MAR-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K053229(SPECIAL)
ATTN: STEVE CHAO PHONE NO : 886 423 594985X240
9, ROAD 36 SE DECISION MADE: 23-MAR-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: MERITS MODEL E SERIES LIFT CHAIRS
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K060212(ABBREVIATED)
ATTN: STEVE CHAO PHONE NO : 886 423 594985
9, ROAD 36 SE DECISION MADE: 07-MAR-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT
MI GWANG CONTACT LENS CO., LTD. 510(k) NO: K051477(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE SE DECISION MADE: 10-MAR-06
B7 510(k) SUMMARY AVAILABLE FROM FDA
GRAND JUNCTION, CO 81505
DEVICE: NEXUS LIGATING CLIP
MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K053255(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE STREET SE DECISION MADE: 14-MAR-06
BELLAIRE, TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROLAB, SPIROLAB II
MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K052140(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 390 622 754777
VIA DEL MAGGIOLINO 125 SE DECISION MADE: 16-MAR-06
ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFIX ANCHOR
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K053339(TRADITIONAL)
ATTN: NANCY L BENNEWITZ PHONE NO : 732-661-0202
125 MAY STREET SE DECISION MADE: 16-MAR-06
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFT ALLOGRAFT FILLER TUBE
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K060161(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-0202
125 MAY ST, STE 300 SE DECISION MADE: 21-MAR-06
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN
NANO-DITECH CO. 510(k) NO: K050975(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 02-MAR-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 2020
NANOGEN, INC. 510(k) NO: K051596(TRADITIONAL)
ATTN: VAN N SCHRAMM PHONE NO : 858-410-4877
10398 PACIFIC CENTER CT. SE DECISION MADE: 13-MAR-06
SAN DIEGO, CA 92121-4340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERX500 FLEXIBLE ARRAY ELECTRODE
NEURO RESOURCE GROUP, INC. 510(k) NO: K053626(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-665-1810
1100 JUPITER RD., STE. 190 SE DECISION MADE: 29-MAR-06
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P-STEM SYSTEM
NEUROSCIENCE THERAPY CORP. 510(k) NO: K050123(TRADITIONAL)
ATTN: JAN MCCOMB PHONE NO : 949-830-3268
135 LAKE STREET SOUTH SE DECISION MADE: 30-MAR-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
KIRKLAND, WA 98033
DEVICE: NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
NOVABONE PRODUCTS, LLC 510(k) NO: K051617(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 06-MAR-06
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGUIDE NEEDLE SET
NUCLETRON CORPORATION 510(k) NO: K060349(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
8671 ROBERT FULTON DR. SE DECISION MADE: 10-MAR-06
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE DIALYSATE PREPARATION MODULE
NXSTAGE MEDICAL, INC. 510(k) NO: K060296(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4746
439 SOUTH UNION ST. SE DECISION MADE: 31-MAR-06
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843
DEVICE: EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF T
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K060475(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 17-MAR-06
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACCU-SOURCE
ONCOLOGY SYSTEMS, INC. 510(k) NO: K051753(TRADITIONAL)
ATTN: JENNIFER WILLIAMS PHONE NO : 217-355-4460
206 N RANDOLPH STREET, STE 300 SE DECISION MADE: 29-MAR-06
CHAMPAIGN, IL 61820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STICK Y EXTENSION SET AND VOLUMETER
ONE STICK LLC 510(k) NO: K060672(TRADITIONAL)
ATTN: TRACY MAGEE PHONE NO : 806-842-3999
P.O. BOX 3575 SE DECISION MADE: 31-MAR-06
LUBBOCK, TX 79452-3575 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KHAN KINETIC TREATMENT DEVICE (KKT-M1)
OPTIMA HEALTH SOLUTIONS INTERNATIO510(k) NO: K060043(TRADITIONAL)
ATTN: BRAM RAMJIAWAN PHONE NO : 204 984 4623
UNIT 303, 828 WEST 8TH AVE. SE DECISION MADE: 23-MAR-06
VANCOUVER, BRITISH COLUMBIA, CANAD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHAN
OPTIVIA MEDICAL LLC 510(k) NO: K053583(TRADITIONAL)
ATTN: ROBERT M KELLEY PHONE NO : 336-748-0686
101 N. CHESTNUT STREET SE DECISION MADE: 31-MAR-06
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27101
DEVICE: PANORAMIC, MODEL 200MA
OPTOS PLC 510(k) NO: K060424(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5815
555 THIRTEENTH ST. N.W. SE DECISION MADE: 17-MAR-06
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
ORTHO DEVELOPMENT CORP. 510(k) NO: K053587(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 17-MAR-06
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: CSS CANNULATED SCREW SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K060428(TRADITIONAL)
ATTN: LEE A STRNAD PHONE NO : 330-869-9563
1815 W. MARKET SE DECISION MADE: 07-MAR-06
AKRON, OH 44313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLOSS E BONE VOID FILLER
OSSACUR AG 510(k) NO: K051047(TRADITIONAL)
ATTN: KRISTI KISTNER PHONE NO : 805-682-8685
975 VERONICA SPRINGS ROAD SE DECISION MADE: 08-MAR-06
SANTA BARBARA, CA 93105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOPORE PCL SCAFFOLD
OSTEOPORE, INC. 510(k) NO: K051093(TRADITIONAL)
ATTN: ALEXANDER YEO PHONE NO : 408-945-8147
958 KRISTIN RIDGE WAY SE DECISION MADE: 17-MAR-06
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K060286(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144
WADE RD. SE DECISION MADE: 17-MAR-06
BASINGSTOKE, HANTS, UNITED KINGDOM510(k) STATEMENT
DEVICE: ELECTROPULSE
PAIN RELIEF TECHNOLOGIES 510(k) NO: K051128(TRADITIONAL)
ATTN: KENDALL GORHAM PHONE NO : 480-231-0975
15440 N. 71ST STREET #215 SE DECISION MADE: 10-MAR-06
SCOTTSDALE, AZ 85254 510(k) STATEMENT
DEVICE: PALOMAR LUXIR FRACTIONAL HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K060069(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 02-MAR-06
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUX1540 HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K060301(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 23-MAR-06
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIC PALPOMETER
PALPOMETER SYSTEMS, INC. 510(k) NO: K060125(TRADITIONAL)
ATTN: LINDSAY ROACH PHONE NO : 250 721 6502
R HUT MCKENZIE AVE. SE DECISION MADE: 16-MAR-06
PO BOX 3075 STN CSC 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, BRITISH COLUMBIA, CANADATHIRD PARTY REVIEW
DEVICE: LC SPRINT NEBULIZER
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K060399(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804-253-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 02-MAR-06
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
PENLON LIMITED 510(k) NO: K053564(TRADITIONAL)
ATTN: BARRY PEARCE PHONE NO : 011 441 243779550
25 BARKER CLOSE SE DECISION MADE: 03-MAR-06
FISHBOURNE, CHICHESTER 510(k) SUMMARY AVAILABLE FROM FDA
WEST SUSSEX, UNITED KINGDOM PO18 8BJ
DEVICE: THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIV
PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K060541(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : +49 703 14631734
HEWLETT PACKARD STR. 2 SE DECISION MADE: 24-MAR-06
BOBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANMECA PROMAX 3D
PLANMECA OY 510(k) NO: K060328(TRADITIONAL)
ATTN: LARS MORING PHONE NO : 358 20 7795500
ASENTAJANKATU 6 SE DECISION MADE: 15-MAR-06
HELSINKI, FINLAND FI-00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
POLYMEDCO, INC. 510(k) NO: K053553(TRADITIONAL)
ATTN: HELEN LANDRICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 09-MAR-06
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: POREX ELECTROSURGERY NEEDLE
POREX SURGICAL, INC. 510(k) NO: K052297(TRADITIONAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-876-3767
15 DART RD. SE DECISION MADE: 28-MAR-06
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAMESH MACROPOROUS PP SURGICAL MESH
PROXY BIOMEDICAL LTD. 510(k) NO: K060520(ABBREVIATED)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 28-MAR-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
PT. MAHAKARYA INTI BUANA 510(k) NO: K053366(TRADITIONAL)
ATTN: SASITHARAN NAIR PHONE NO : 626 179 44880
J1. SEI BELUMAI, DESA DALU 10 SE DECISION MADE: 30-MAR-06
A DUSUN I NO. 18, TANJUNG 510(k) SUMMARY AVAILABLE FROM FDA
MORAWA, SUMUT, INDONESIA 20362
DEVICE: MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
QUANTIMETRIX CORP. 510(k) NO: K060417(SPECIAL)
ATTN: PHONE NO :
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 21-MAR-06
REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
QUANTUM ORTHOPEDICS, INC. 510(k) NO: K060491(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 13-MAR-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM
RADIANCY (ISRAEL) LTD. 510(k) NO: K060411(TRADITIONAL)
ATTN: MARGARET FOURTE PHONE NO : 845-398-1647
40 RAMLAND ROAD SE DECISION MADE: 22-MAR-06
SUITE 10 510(k) SUMMARY AVAILABLE FROM FDA
ORANGEBURG, NY 10962
DEVICE: MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
RAND S.R.L. 510(k) NO: K052555(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9533
7611 NORTHLAND DRIVE SE DECISION MADE: 15-MAR-06
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX IMOLA
RANDOX LABORATORIES, LTD. 510(k) NO: K052914(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 31-MAR-06
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
REAL TONE TECHNOLOGY CORP. 510(k) NO: K060077(TRADITIONAL)
ATTN: TOM WANG PHONE NO : 008 621 54955946
XI HUANG ROAD; XINZHUANG TOWN SE DECISION MADE: 08-MAR-06
SHANGHAI, CHINA 201110 510(k) STATEMENT
DEVICE: RDI HSFERRITIN KIT
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K053211(TRADITIONAL)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
19 CROSBY DR. SUITE 30 SE DECISION MADE: 13-MAR-06
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: FERRITIN CALIBRATOR SET, CATALOG NO. 8203
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K053291(ABBREVIATED)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
19 CROSBY DR. SUITE 30 SE DECISION MADE: 13-MAR-06
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
REFRACTEC, INC. 510(k) NO: K053475(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-784-2600
5 JENNER, SUITE 150 SE DECISION MADE: 03-MAR-06
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC 510(k) NO: K053102(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900
3585 ENGINEERING DR, STE 250 SE DECISION MADE: 10-MAR-06
NORCROSS, GA 30092 510(k) STATEMENT
DEVICE: BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
REGENT MEDICAL AMERICAS, LLC 510(k) NO: K053442(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900
3585 ENGINEERING DR, STE 250 SE DECISION MADE: 07-MAR-06
NORCROSS, GA 30092 510(k) STATEMENT
DEVICE: FRAXEL SR LASER SYSTEM
RELIANT TECHNOLOGIES, INC. 510(k) NO: K053047(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200
260 SHERIDAN AVE. SE DECISION MADE: 20-MAR-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94306
DEVICE: FRAXEL II SR LASER SYSTEM AND ACCESSORIES
RELIANT TECHNOLOGIES, INC. 510(k) NO: K060310(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-641-5861
464 ELLIS ST. SE DECISION MADE: 29-MAR-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
RESONANCE INNOVATIONS LLC 510(k) NO: K060689(SPECIAL)
ATTN: RANDALL JONES PHONE NO : 402-934-2650
12530 HARNEY CIRCLE SE DECISION MADE: 31-MAR-06
OMAHA, NE 68154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
RESTORATIVE THERAPIES INC. 510(k) NO: K060032(SPECIAL)
ATTN: ANDREW BARRISKILL PHONE NO : 310-691-5467
2363 BOSTON ST. SE DECISION MADE: 10-MAR-06
BALTIMORE, MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVS - CATHETER, MODELS 1107100 & 1107060
RICHTER & ROTHE AG 510(k) NO: K052844(TRADITIONAL)
ATTN: JOACHIM RICHTER PHONE NO : +49 341 22451220
WILHELM LEUSCHNER PLATZ 12 SE DECISION MADE: 20-MAR-06
LEIPZIG, GERMANY 04107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS 6000 SERIES SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K060373(SPECIAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE ROAD SE DECISION MADE: 13-MAR-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM CONTROL SET
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060429(ABBREVIATED)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 15-MAR-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQPACS
S.C. INFO WORLD S.R.L. 510(k) NO: K060263(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 15-MAR-06
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
SAUTER AG 510(k) NO: K060337(SPECIAL)
ATTN: HANS STADLER PHONE NO : 417 164 48500
ZELGSTRASSE 8 SE DECISION MADE: 08-MAR-06
SULGEN TG, SWITZERLAND CH-8583 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETR
SCANTIBODIES LABORATORY, INC. 510(k) NO: K060420(SPECIAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 01-MAR-06
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: COMPASS COMPRESSION ASSIST HANDLE
SEMLER TECHNOLOGIES, INC. DBA 510(k) NO: K053398(TRADITIONAL)
ATTN: HERBERT J SEMLER PHONE NO : 800-525-2555
2326 NW EVERETT ST. SE DECISION MADE: 10-MAR-06
PORTLAND, OR 97027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM-50 PULSE OXIMETER
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K052693(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 30-MAR-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED STERILE VINYL GLOVE, CLEAR
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K053521(TRADITIONAL)
ATTN: WILLIAM WANG PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 29-MAR-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING
SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K060229(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 15-MAR-06
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: DA VINCI FEMTOSECOND SURGICAL LASER
SIE LTD SURGICAL INSTRUMENT ENGINE510(k) NO: K053511(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 10-MAR-06
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052202(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PARKWAY, E-50 SE DECISION MADE: 07-MAR-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONCOR EXPRESSION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060226(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925-246-8200
4040 NELSON AVE. SE DECISION MADE: 15-MAR-06
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH 64 AND BIOGRAPH 40
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060631(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703
810 INNOVATION DR. SE DECISION MADE: 17-MAR-06
KNOXVILLE, TN 37934 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
SIGNAL MEDICAL CORP. 510(k) NO: K051510(TRADITIONAL)
ATTN: LOUIS A SERAFIN PHONE NO : 810-364-7070
400 PYRAMID DR. SE DECISION MADE: 22-MAR-06
MARYSVILLE, MI 48040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINMED POSITIONING DEVICES
SINMED BV 510(k) NO: K060737(TRADITIONAL)
ATTN: CAROLINE DE KEIJZER PHONE NO : 311 823 94495
6,PASTEURSTRAAT SE DECISION MADE: 31-MAR-06
REEUWIJK, NETHERLANDS 2811 DX 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
SINTEA BIOTECH, INC. 510(k) NO: K060513(SPECIAL)
ATTN: GUSTAVO A RIOS PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 10-MAR-06
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROENDO
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K052515(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 31-MAR-06
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI RADIO-CAPITELLAR IMPLANT
SMALL BONE INNOVATIONS INC. 510(k) NO: K060038(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 215-428-1791
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 30-MAR-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLONE, MODEL MAICAM 180
SPECTRICA 510(k) NO: K060486(TRADITIONAL)
ATTN: STEVE JUDE PHONE NO : 613 225 5554
15 ANTARES DRIVE SE DECISION MADE: 23-MAR-06
# 2 510(k) SUMMARY AVAILABLE FROM FDA
OTTAWA, ONTARIO, CANADA K2E 7Y9
DEVICE: SPINAL USA CEMENT RESTRICTOR SYSTEM
SPINAL USA 510(k) NO: K060132(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-992-7668
213 EASTSIDE LANE SE DECISION MADE: 16-MAR-06
BRANDON, MS 39047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 4
ST. JUDE MEDICAL 510(k) NO: K053217(TRADITIONAL)
ATTN: DEANNA HUGHES PHONE NO : 818-493-2629
15900 VALLEY VIEW CT. SE DECISION MADE: 08-MAR-06
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPE1 1 -PLY SURGICAL GOWNS
STANDARD TEXTILE CO., INC. 510(k) NO: K060181(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 07-MAR-06
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: ONE TRAY SEALED STERILIZATION CONTAINER
STERILE CONTAINMENT TECHNOLOGY, LL510(k) NO: K052567(TRADITIONAL)
ATTN: GAGE GARMAN PHONE NO : 510-412-6383
1301 QUARRY COURT, SUITE 204 SE DECISION MADE: 13-MAR-06
POINT RICHMOND, CA 94801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERSTICK A&O
STICK TECH LTD. 510(k) NO: K051953(TRADITIONAL)
ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640
80 PARKWAY WEST SE DECISION MADE: 21-MAR-06
MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INJECTABLE CEMENT
STRYKER CORP. 510(k) NO: K060061(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 877-534-2464
750 TRADE CENTRE WAY SE DECISION MADE: 01-MAR-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
KALAMAZOO, MI 49001
DEVICE: XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K060361(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 06-MAR-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPH
SUNRISE MEDICAL 510(k) NO: K060531(SPECIAL)
ATTN: JOSEPH OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 17-MAR-06
SOMERSET, PA 15501-2125 510(k) STATEMENT
DEVICE: SURGICOUNT SAFETY-SPONGE SYSTEM
SURGICOUNT MEDICAL 510(k) NO: K060076(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 14-MAR-06
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND ALL-IN-ONE
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K060469(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE, SUITE 6000 SE DECISION MADE: 28-MAR-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGEYES PS HYBRID CONTACT LENS
SYNERGEYES, INC. 510(k) NO: K060102(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 15-MAR-06
SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: POLARIS WR, ST APPLICATOR
SYNERON MEDICAL LTD. 510(k) NO: K053616(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 490 96200
APPOLO BLDG., SE DECISION MADE: 14-MAR-06
INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM ILLIT, ISRAEL
DEVICE: NORIAN SRS FAST SET PUTTY
SYNTHES (USA) 510(k) NO: K060406(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 484-356-9728
1230 WILSON DR. SE DECISION MADE: 20-MAR-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORIAN SRS BONE VOID FILLER
SYNTHES (USA) 510(k) NO: K060408(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 484-356-9728
1230 WILSON DR. SE DECISION MADE: 21-MAR-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHDEVICE GUIDEWIRE
TECHDEVICE CORPORATION 510(k) NO: K053251(TRADITIONAL)
ATTN: LEIGH HAYWARD PHONE NO : 617-972-5808
650 PLEASANT ST. SE DECISION MADE: 08-MAR-06
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
TECO DIAGNOSTICS 510(k) NO: K060120(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 27-MAR-06
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINE-FIX BIOMIMETIC BONE CEMENT
TEKNIMED SA 510(k) NO: K043593(TRADITIONAL)
ATTN: J. D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 17-MAR-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEROX INFUSION CATHETER, MODEL INCA-1
THEROX, INC. 510(k) NO: K052637(TRADITIONAL)
ATTN: DAVID W MULLIS JR. PHONE NO : 770-722-1643
2400 MICHELSON DR. SE DECISION MADE: 08-MAR-06
IRVINE, CA 92612-1310 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MYOTRAC INFINITI ELECTRICAL STIMULATOR
THOUGHT TECHNOLOGY LTD. 510(k) NO: K053434(TRADITIONAL)
ATTN: SURESH R SUGIRTHARAJA PHONE NO : 514 489 8251
2180 BELGRAVE AVE. SE DECISION MADE: 15-MAR-06
MONTREAL, QUEBEC, CANADA H4A 2LB 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TIANJIN MEDIS DISPOSABLE INFUSION SET
TIANJIN MEDIS INTERNATIONAL TRADE 510(k) NO: K060082(ABBREVIATED)
ATTN: CINDY WANG PHONE NO : 862 288 379926
WANSHUN GARDEN C 1801 SE DECISION MADE: 31-MAR-06
89# HUANGPU NAN ROAD 510(k) STATEMENT
HEXI DISTRICT, TIANJIN, CHINA 300201
DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
TORNIER 510(k) NO: K060209(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
161 RUE LAVOISIER SE DECISION MADE: 02-MAR-06
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
TRIOSYN CORP. 510(k) NO: K051542(TRADITIONAL)
ATTN: KYLE ANDERSON PHONE NO : 802-865-5084
1191 SOUTH BROWNELL ROAD SE DECISION MADE: 17-MAR-06
WILLISTON, VT 05495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOFLOW 700, CRYOFLOW 1000
UNIPHY ELEKTROMEDIZIN GMBH & CO. K510(k) NO: K052310(ABBREVIATED)
ATTN: NICO BEUN PHONE NO : 113 289 510510
6A PASWEG SE DECISION MADE: 15-MAR-06
BILZEN, BELGIUM 3740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U2 TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP. 510(k) NO: K051640(TRADITIONAL)
ATTN: GENE HUANG PHONE NO : 886 357 73351
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 01-MAR-06
HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
VALLEYLAB 510(k) NO: K053290(TRADITIONAL)
ATTN: CHARLES M COPPERBERG PHONE NO : 303-530-6247
5920 LONGBOW DR. SE DECISION MADE: 15-MAR-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENFIL FLOW
VERICOM CO., LTD. 510(k) NO: K060637(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 823 144 12881
#606,5TH DONGYOUNG VENTURESTEL SE DECISION MADE: 16-MAR-06
199-32, ANYANG 7-DONG,MANAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG-SI, GYEONGGI-DO, REPUBLIC OTHIRD PARTY REVIEW
DEVICE: MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
VISION-SCIENCES, INC. 510(k) NO: K053560(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 16-MAR-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITREA2 VERSION 3.8.1
VITAL IMAGES, INC. 510(k) NO: K060378(ABBREVIATED)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9510
5850 OPUS PARKWAY, SE DECISION MADE: 09-MAR-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343 THIRD PARTY REVIEW
DEVICE: PILL PHONE
VOCEL 510(k) NO: K060298(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SE DECISION MADE: 29-MAR-06
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: M-VU VIEWER STATION
VUCOMP, INC. 510(k) NO: K060451(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 22-MAR-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: VYGON LATEX FREE BIONECTOR
VYGON CORP. 510(k) NO: K052881(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 02-MAR-06
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR
WALLAC OY 510(k) NO: K050709(TRADITIONAL)
ATTN: RAIJA KOSKIVAARA PHONE NO : 358 226 78111
MUSTIONKATU 6 SE DECISION MADE: 08-MAR-06
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
WELL HOME HEALTH PRODUCTS CO. 510(k) NO: K060251(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 08-MAR-06
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K052785(SPECIAL)
ATTN: GRACE CHANG PHONE NO : 886 229 282112
5 FL., STE 504,EMPIRE CENTRE SE DECISION MADE: 17-MAR-06
68 MODY ROAD, TSIMSHATSUIM 510(k) SUMMARY AVAILABLE FROM FDA
KOWLOON, HONG KONG
DEVICE: HYPEROX 101
WJO, INC 510(k) NO: K053498(TRADITIONAL)
ATTN: CHRIS BELLETIERI PHONE NO : 215-826-8050
424 MILL STREET AT CANAL'S END SE DECISION MADE: 15-MAR-06
PLAZA 510(k) SUMMARY AVAILABLE FROM FDA
BRISTOL, PA 19007
DEVICE: ALLOMATRIX CUSTOM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K053319(TRADITIONAL)
ATTN: BRIAN YOUNG PHONE NO : 901-867-4120
5677 AIRLINE RD. SE DECISION MADE: 06-MAR-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
ZARGIS MEDICAL CORP. 510(k) NO: K060197(SPECIAL)
ATTN: JOHN KALLASSY PHONE NO : 888-773-3669
2 RESEARCH WAY SE DECISION MADE: 29-MAR-06
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORBITE
ZHERMACK S.P.A. 510(k) NO: K053619(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 01-MAR-06
BEND, OR 97702 510(k) STATEMENT
DEVICE: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
ZIMMER GMBH 510(k) NO: K053536(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 16-MAR-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 288
TOTAL WITH SUMMARIES 259
TOTAL WITH STATEMENTS 29
-
-