-
Medical Devices
-
August 2002 510(k) Clearances
Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance.
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-AUG-2002 THROUGH 31-AUG-2002
DEVICE: RELYX RMGIP
3M COMPANY 510(k) NO: K022476(SPECIAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 02-AUG-02
ST PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINPRO PROPHY POWDER
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K021450(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 01-AUG-02
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T VESSEL CANNULAS
3T MEDICAL SYSTEMS, LLC. 510(k) NO: K020768(TRADITIONAL)
ATTN: ROBERT P EATON PHONE NO : 303-838-2407
12553 S. WAMBLEE VALLEY ROAD SE DECISION MADE: 23-AUG-02
CONIFER, CO 80433-6204 510(k) STATEMENT
DEVICE: ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
INTL., INC. 510(k) NO: K022330(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 26-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: LITE MINERAL OIL
INTL., INC. 510(k) NO: K022332(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 23-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
INTL., INC. 510(k) NO: K022334(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: ALLGRAD AND ALLGRAD100
INTL., INC. 510(k) NO: K022335(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 23-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
INTL., INC. 510(k) NO: K022352(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: ACIDIFIED TYRODES SOLUTION
INTL., INC. 510(k) NO: K022547(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: PVP (POLYVINYLPYRROLIDONE)
INTL., INC. 510(k) NO: K022590(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 30-AUG-02
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
A-MED SYSTEMS, INC. 510(k) NO: K020529(TRADITIONAL)
ATTN: CYNTHIA G ROYSTER PHONE NO : 916-375-7400
2491 BOATMAN AVE. SE DECISION MADE: 26-AUG-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNF
AAP IMPLANTATE AG 510(k) NO: K021782(TRADITIONAL)
ATTN: DIPL-ING CHRISTIAN ABEL PHONE NO : 493 075 019190
LORENZWEG 5 SE DECISION MADE: 26-AUG-02
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASU
ABBOTT LABORATORIES 510(k) NO: K021960(TRADITIONAL)
ATTN: JANET S CONNOLLY PHONE NO : 781-276-6230
4-A CROSBY DR. SE DECISION MADE: 16-AUG-02
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
ABBOTT LABORATORIES 510(k) NO: K022203(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
DEPT 0389 BLDG J-45 SE DECISION MADE: 01-AUG-02
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: ACCESSAED, MODEL 9100-0300
ACCESS CARDIOSYSTEMS, INC. 510(k) NO: K020984(TRADITIONAL)
ATTN: DAVID BARASH PHONE NO : 978-371-4985
150 BAKER AVENUE EXTENSION SE DECISION MADE: 14-AUG-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
ACMI CORPORATION 510(k) NO: K022480(SPECIAL)
ATTN: JOHN A DELUCIA PHONE NO : 508-804-2617
136 TURNPIKE ROAD SE DECISION MADE: 22-AUG-02
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
ACUSON CORP. 510(k) NO: K022567(TRADITIONAL)
ATTN: JERRY W TSUTSUMI PHONE NO : 650-943-7286
1220 CHARLESTON RD. SE DECISION MADE: 13-AUG-02
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
ACUTRONIC MEDICAL SYSTEMS AG 510(k) NO: K012693(TRADITIONAL)
ATTN: TERRY TORZALA PHONE NO : 520-743-7874
PO BOX 85820 SE DECISION MADE: 01-AUG-02
TUCSON, AZ 85754-5820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE BLOOD POOL SPECT (QBS)
ADAC LABORATORIES 510(k) NO: K022428(TRADITIONAL)
ATTN: COLEEN COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 06-AUG-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALPHA INFUSION PUMP AND CATHETERS
ADVANCED INFUSION, INC. 510(k) NO: K021964(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-9857
6200 SOUTH MCCLINTOCK #6 SE DECISION MADE: 12-AUG-02
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAMITRODE S-SERIES (S4 AND S8) LEADS
ADVANCED NEUROMODULATION SYSTEM,IN510(k) NO: K022222(SPECIAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8000
6501 WINDCREST DRIVE,SUTE 100 SE DECISION MADE: 08-AUG-02
PLANO, TX 75024 510(k) STATEMENT
DEVICE: APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K013003(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482
33 TECHNOLOGY DR. SE DECISION MADE: 28-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
ADVEN MEDICAL 510(k) NO: K021528(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 21-AUG-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART SILICONE SHEETING
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K022223(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 08-AUG-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART CALF IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K022511(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 26-AUG-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADC DENTAL
AGFA CORP. 510(k) NO: K021542(TRADITIONAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY STREET SE DECISION MADE: 06-AUG-02
GREENVILLE, SC 29602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDSTATION
AISOFTW@RE MEDICAL, S.P.A. 510(k) NO: K021934(TRADITIONAL)
ATTN: DIANA UPTON PHONE NO : 201-692-1945
719 CATALPA AVE SE DECISION MADE: 12-AUG-02
TEANECK, NJ 07666 510(k) STATEMENT
DEVICE: ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K022209(SPECIAL)
ATTN: RENNE L FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIRCLE SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
ALCON UNIVERSAL, LTD. 510(k) NO: K021143(TRADITIONAL)
ATTN: RALPH H LARSEN PHONE NO : 817-551-4702
6201 SOUTH FREEWAY SE DECISION MADE: 08-AUG-02
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022564(SPECIAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DRIVE SE DECISION MADE: 30-AUG-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY STAT HCG DIPSTICK TEST
ALIDEX, INC. 510(k) NO: K021386(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
12277 134TH CT., N.E., #100 SE DECISION MADE: 05-AUG-02
REDMOND, WA 98052 510(k) STATEMENT
DEVICE: GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYST
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K012931(TRADITIONAL)
ATTN: LANCE MARCONI PHONE NO : 847-785-3312
1500 WAUKEGAN RD. SE DECISION MADE: 20-AUG-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL CORP. 510(k) NO: K012708(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 13-AUG-02
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA DRIVE SYSTEM
ALPHA OMEGA LTD. 510(k) NO: K013396(SPECIAL)
ATTN: AJWAD AKASHI PHONE NO : 972 465 63327
HA'AVODA ST., P.O. BOX 810 SE DECISION MADE: 07-AUG-02
NAZARETH ILLIT, ISRAEL 17105 510(k) STATEMENT
DEVICE: SCREWLINE
ALTATEC BIOTECHNOLOGIES N.A., INC.510(k) NO: K022425(SPECIAL)
ATTN: ROBERT J SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 14-AUG-02
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S &
ANDERSEN PRODUCTS, INC. 510(k) NO: K021493(SPECIAL)
ATTN: WENDY HEDRICK PHONE NO : 336-376-3000
3202 CAROLINE DR., SE DECISION MADE: 30-AUG-02
HEALTH SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HAW RIVER, NC 27258-8710
DEVICE: BABY TEETHER, MODEL 20104
ANGELINA TRADING, INC. 510(k) NO: K014023(TRADITIONAL)
ATTN: JOHN CHANG PHONE NO : 213-362-0899
947 S. ALAMEDA STREET #A SE DECISION MADE: 02-AUG-02
LOS ANGELES, CA 90021 510(k) STATEMENT
DEVICE: MODIFICATION TO INSTA CHECK MULTI-DRUG SCREEN PANEL THC/COC.MOR
APPLIED BIOTECH, INC. 510(k) NO: K022392(SPECIAL)
ATTN: DOUG HARDING PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 15-AUG-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC O
ARGUS BIOMEDICAL PTY LTD 510(k) NO: K013756(TRADITIONAL)
ATTN: BARBARA S FANT PHONE NO : 513-961-8200
3307 CLIFTON AVE., SE DECISION MADE: 29-AUG-02
CINCINNATI, OH 45220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHEATH ADAPTER, MODEL SA-09847
ARROW INTL., INC. 510(k) NO: K021723(TRADITIONAL)
ATTN: BRANDON EPTING PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 08-AUG-02
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTERIA BLOOD FILTER
ARTERIA MEDICAL SCIENCE, INC. 510(k) NO: K021293(TRADITIONAL)
ATTN: ALAN HINTON PHONE NO : 707-422-1778
22 HILL ST. SE DECISION MADE: 22-AUG-02
NEWBURYPORT, MA 01950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
ARTHROCARE CORP. 510(k) NO: K022543(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 30-AUG-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMO THERMOREGULATION INTERFACE ACCESSORY
AVACORE TECHNOLOGIES, INC. 510(k) NO: K014210(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 415-531-1932
251 HIGH STREET, SUITE B SE DECISION MADE: 16-AUG-02
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASTIM KIT
AXELGAARD MFG. CO., LTD. 510(k) NO: K013532(TRADITIONAL)
ATTN: DAN JEFFERY PHONE NO : 760-723-7554
1667 S. MISSION ROAD SE DECISION MADE: 22-AUG-02
FALLBROOK, CA 92028-4115 510(k) STATEMENT
DEVICE: INTROCAN SAFETY IV CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K020785(TRADITIONAL)
ATTN: AMY S KRALL PHONE NO : 610-266-0500
824 TWELFTH AVE. SE DECISION MADE: 28-AUG-02
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFIX CATHETER CONNECTOR
B. BRAUN MEDICAL, INC. 510(k) NO: K022019(TRADITIONAL)
ATTN: AMY S KRALL PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 01-AUG-02
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFUSOR COMPACT WITH FM SYSTEM
B. BRAUN MEDICAL, INC. 510(k) NO: K022575(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150 SE DECISION MADE: 21-AUG-02
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LEN
BAUSCH & LOMB INCORPORATED 510(k) NO: K022128(TRADITIONAL)
ATTN: DEBRA L KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN STREET SE DECISION MADE: 22-AUG-02
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID-FILL TUBESET, MODEL 90005
BAXA CORP. 510(k) NO: K022523(TRADITIONAL)
ATTN: KARL STEINBECK PHONE NO : 303-617-2181
13760 EAST ARAPAHOE RD. SE DECISION MADE: 12-AUG-02
ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION S
BECTON DICKINSON & CO. 510(k) NO: K022426(SPECIAL)
ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 08-AUG-02
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MC
BECTON, DICKINSON AND COMPANY 510(k) NO: K021954(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 01-AUG-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K022172(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 12-AUG-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
BEST MANUFACTURING COMPANY 510(k) NO: K022024(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 01-AUG-02
MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SER
BIO-RAD 510(k) NO: K022525(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIE
BIO-RAD 510(k) NO: K022529(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO ROAD SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S
BIO-RAD 510(k) NO: K022707(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 22-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AUTOTAC SYSTEM TITANIUM TACK
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K022790(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 28-AUG-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: MODIFICATION TO THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K022795(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 30-AUG-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: CERALAS D DIODE LASER SYSTEM, MODEL # D50
BIOLITEC, INC. 510(k) NO: K013691(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 13-AUG-02
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEPFLO, MODEL 101501
BIOMEC, , INC. 510(k) NO: K020607(ABBREVIATED)
ATTN: TRACEY H WIELINSKI PHONE NO : 216-937-2800
1771 EAST 30TH STREET SE DECISION MADE: 30-AUG-02
CLEVELAND, OH 44114-4407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDA D-DIMER
BIOMERIEUX, INC. 510(k) NO: K021877(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 07-AUG-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
BIOMERIEUX, INC. 510(k) NO: K022045(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM ROAD SE DECISION MADE: 15-AUG-02
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED P
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K022463(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 16-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR STABILIZED TIBIAL BEARINGS
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K022586(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 15-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM ANKLE ARTHRODESIS NAIL
BIOMET, INC. 510(k) NO: K021786(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
56 EAST BELL DR. SE DECISION MADE: 26-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MM PEDIATRIC FLEX NAIL
BIOMET, INC. 510(k) NO: K022531(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 BELL DRIVE SE DECISION MADE: 26-AUG-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOTEST HEMOGLOBIN MEASURING SYSTEM
BIOTEST MEDIZINTECHNIK GMBH 510(k) NO: K020710(ABBREVIATED)
ATTN: MARK LICATA PHONE NO : 804-828-9329
614 N 4TH STREET SE DECISION MADE: 14-AUG-02
RICHMOND, VA 23219 510(k) STATEMENT
DEVICE: UNINHIBITED
BISCO, INC. 510(k) NO: K021503(TRADITIONAL)
ATTN: STEPHEN (STEVE) SMITH PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 01-AUG-02
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM SPACER
BLACKSTONE MEDICAL, INC. 510(k) NO: K022399(SPECIAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 06-AUG-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
BLACKSTONE MEDICAL, INC. 510(k) NO: K022605(SPECIAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKDALE DR. SE DECISION MADE: 21-AUG-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOLTON PTA CATHETER
BOLTON MEDICAL, INC. 510(k) NO: K021996(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-797-0014
16-00 POLLITT DR. SE DECISION MADE: 23-AUG-02
FAIR LAWN, NJ 07410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERAL STENT
BOSTON SCIENTIFIC CORP. 510(k) NO: K013784(TRADITIONAL)
ATTN: JANET A MCGRATH PHONE NO : 508-652-8726
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 08-AUG-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PRO
BOSTON SCIENTIFIC CORP. 510(k) NO: K020120(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 02-AUG-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR SE MICROSPHERES
BOSTON SCIENTIFIC CORP. 510(k) NO: K022427(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 22-AUG-02
DIX AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
GLENS FALLS, NY 12801-3864
DEVICE: BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K021735(TRADITIONAL)
ATTN: CANDICE BURNS PHONE NO : 763-494-2845
ONE SCIMED PLACE SE DECISION MADE: 08-AUG-02
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOYD DELIVERY UNIT
BOYD INDUSTRIES, INC. 510(k) NO: K020833(TRADITIONAL)
ATTN: BRUCE LIVINGSTON PHONE NO : 727-561-9292
12900 44TH STREET NORTH SE DECISION MADE: 08-AUG-02
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMA SNORING MIKE, MODEL 0540
BRAEBON MEDICAL CORP. 510(k) NO: K020312(TRADITIONAL)
ATTN: RICHARD A BONATO PHONE NO : 613 831 6690
120 WALGREEN DRIVE SE DECISION MADE: 07-AUG-02
SUITE 1 510(k) STATEMENT
RR#3 CARP, ONTARIO, CANADA KOA 1LO
DEVICE: PATXFER
BRAINLAB AG 510(k) NO: K021583(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 12-AUG-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSSEOUS IMPLANT
BRANEMARK INTEGRATION AB 510(k) NO: K021355(TRADITIONAL)
ATTN: RICKARD BRANEMARK PHONE NO : 460 317 601060
LILLA BOMMEN 1 SE DECISION MADE: 30-AUG-02
GOTBORG, SWEDEN SE-411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRESAGEN CATHETER, MODEL CS-3000
BRESAGEN, INC. 510(k) NO: K021481(TRADITIONAL)
ATTN: JOHN KUCHARCZYK PHONE NO : 706-613-9878
111 RIVER BEND ROAD SE DECISION MADE: 06-AUG-02
ATHENS, GA 30605 510(k) STATEMENT
DEVICE: BRUNO ELECTRA-RIDE, MODEL SRE-2700
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K022509(SPECIAL)
ATTN: RICHARD KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DRIVE SE DECISION MADE: 13-AUG-02
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
C.R. BARD, INC. 510(k) NO: K022350(TRADITIONAL)
ATTN: BRIAN A KANERVIKO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 23-AUG-02
P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
C.R. BARD, INC. 510(k) NO: K022434(TRADITIONAL)
ATTN: BETH A ZIS PHONE NO : 978-262-4866
129 CONCORD ROAD SE DECISION MADE: 05-AUG-02
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821 THIRD PARTY REVIEW
DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
C.R. BARD, INC. 510(k) NO: K022561(TRADITIONAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 23-AUG-02
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F 900
C.S.O. S.R.L. 510(k) NO: K022054(TRADITIONAL)
ATTN: R. BRENT MINER PHONE NO : 716-632-1988
197 BELVOIR ROAD SE DECISION MADE: 06-AUG-02
WILLIAMSVILLE, NY 14221 510(k) STATEMENT
DEVICE: C.T.M. POWER CHAIR, MODEL HS-2800
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K021617(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DRIVE SE DECISION MADE: 02-AUG-02
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMLIGHT
CAO GROUP, INC. 510(k) NO: K020057(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-256-9282
8685 SOUTH 7TH WEST SE DECISION MADE: 27-AUG-02
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRC-15BT
CAPINTEC, INC. 510(k) NO: K020150(TRADITIONAL)
ATTN: MARY ANNE DELL PHONE NO : 412-963-1988
540 ALPHA DR. SE DECISION MADE: 02-AUG-02
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K021574(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PEKERIS ST. SE DECISION MADE: 12-AUG-02
PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
CARDIOMED SUPPLIES, INC. 510(k) NO: K021080(TRADITIONAL)
ATTN: DONNA MCCOMB PHONE NO : 905 888 1965
5 GORMLEY INDUSTRIAL AVENUE SE DECISION MADE: 29-AUG-02
GORMLEY, ONTARIO, CANADA L0H 1G0 510(k) STATEMENT
DEVICE: CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
CARDIOMEDICS, INC. 510(k) NO: K022107(TRADITIONAL)
ATTN: GARY CLARK PHONE NO : 949-863-2500
18872 BARDEEN AVE. SE DECISION MADE: 08-AUG-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENOXAPARIN TEST CARD
CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K013305(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 800-247-4234
9401 GLOBE CENTER DR. SE DECISION MADE: 23-AUG-02
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, IN
CHAY MEDICAL, LLC. 510(k) NO: K021781(TRADITIONAL)
ATTN: STEPHEN C PEARSON PHONE NO : 707-481-3204
3257 ROUTE 128 SE DECISION MADE: 30-AUG-02
CALISTOGA, CA 94515 510(k) STATEMENT
DEVICE: CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
CLINIQA CORPORATION 510(k) NO: K022232(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 01-AUG-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SY
CLINIQA CORPORATION 510(k) NO: K022491(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 27-AUG-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: REPHRESH VAGINAL GEL
COLUMBIA LABORATORIES, INC. 510(k) NO: K021737(TRADITIONAL)
ATTN: SUSAN A WITHAM PHONE NO : 973-994-3999
100 NORTH VILLAGE AVENUE SE DECISION MADE: 26-AUG-02
SUITE 32 510(k) STATEMENT
ROCKVILLE CENTRE, NY 11570
DEVICE: SURGISIS STAPLE LINE REINFORCEMENT
COOK BIOTECH, INC. 510(k) NO: K022044(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 23-AUG-02
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYDNEY IVF CULTURE OIL
COOK UROLOGICAL, INC. 510(k) NO: K022002(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 12-AUG-02
P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460
DEVICE: 7.0 FR. ENDOBRONCHIAL BLOCKER
COOK, INC. 510(k) NO: K021920(SPECIAL)
ATTN: APRIL LAVENDER PHONE NO : 800-468-1379
P.O. BOX 489 SE DECISION MADE: 14-AUG-02
BLOOMINGTON, IN 47402-0489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K021898(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 14-AUG-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 507EL VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC. 510(k) NO: K022435(SPECIAL)
ATTN: ALEX KAPLAN PHONE NO : 262-798-8282
20925 CROSSROADS CIRCLE SE DECISION MADE: 14-AUG-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT VISION PET SCANNER, MODELS 3000 & 5000
CTI PET SYSTEMS, INC. 510(k) NO: K021633(TRADITIONAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 14-AUG-02
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
CURELIGHT LTD 510(k) NO: K013623(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 16-AUG-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEIN S AC
DADE BEHRING, INC. 510(k) NO: K022290(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 27-AUG-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170
DATASCOPE CORP. 510(k) NO: K020550(TRADITIONAL)
ATTN: RUSSELL OLSEN PHONE NO : 201-995-8391
800 MACARTHUR BLVD. SE DECISION MADE: 28-AUG-02
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA HMEF 500
DATEX-OHMEDA 510(k) NO: K021265(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 30-AUG-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
DATEX-OHMEDA 510(k) NO: K022507(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 23-AUG-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMOD
DAYTON WATER SYSTEMS 510(k) NO: K021352(SPECIAL)
ATTN: DAYNE GILLELAND PHONE NO : 937-461-5225
430 LEO ST. SE DECISION MADE: 01-AUG-02
DAYTON, OH 45404 510(k) STATEMENT
DEVICE: TAILWIND
DELTAGLIDE 510(k) NO: K022704(TRADITIONAL)
ATTN: JERE PERCHY PHONE NO : 203-230-0301
3 INDUSTRIAL CIRCLE SE DECISION MADE: 27-AUG-02
HAMDEN, CT 06517 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
DELTEC, INC. 510(k) NO: K020655(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 13-AUG-02
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIPPER PLUS NEEDLE
DELTEC, INC. 510(k) NO: K021999(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 13-AUG-02
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEAL & PROTECT PROTECTIVE SEALANT
DENTSPLY INTL. 510(k) NO: K021805(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 19-AUG-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
DEPUY ACROMED 510(k) NO: K022246(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 02-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ISOLA SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K022285(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 13-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
DEPUY ACROMED 510(k) NO: K022623(SPECIAL)
ATTN: FRANK MAAS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 27-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFIX EXTERNAL FIXATION SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K021933(TRADITIONAL)
ATTN: CHERYL K HASTINGS PHONE NO : 574-372-7006
700 ORTHOPAEDIC DR. SE DECISION MADE: 26-AUG-02
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
DIAGNOSTIC CHEMICALS, LTD. (USA) 510(k) NO: K022538(SPECIAL)
ATTN: MIKE BERG PHONE NO : 949-643-0406
26371 EVA STREET SE DECISION MADE: 23-AUG-02
LAGUNA HILLS, CA 92656 510(k) STATEMENT
DEVICE: IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K022603(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 21-AUG-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADDERSCAN BVI 6100
DIAGNOSTIC ULTRASOUND CORP. 510(k) NO: K022153(TRADITIONAL)
ATTN: RUSS GARRISON PHONE NO : 425-867-1348
21222 30TH DRIVE SE, STE. 120 SE DECISION MADE: 15-AUG-02
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLASH-LITE LED DENTAL CURING LIGHT
DISCUS DENTAL, INC. 510(k) NO: K022184(TRADITIONAL)
ATTN: GARRY L HOLLAR PHONE NO : 310-845-8345
8550 HIGUERA STREET SE DECISION MADE: 20-AUG-02
CULVER CITY, CA 91761 510(k) STATEMENT
DEVICE: DISETRONIC D-TRON INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K021725(SPECIAL)
ATTN: SANDRA SONIEC PHONE NO : 413 442 42884
KIRCHBERSTRASSE 190, POSTFACH SE DECISION MADE: 02-AUG-02
BURGDORF, SWITZERLAND CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILA
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K021724(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 19-AUG-02
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS H LASER FIBER CABLES
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K022544(SPECIAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 21-AUG-02
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
DRAEGER MEDICAL, INC. 510(k) NO: K022031(TRADITIONAL)
ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 29-AUG-02
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
E-CARE TECHNOLOGY CORPORATION 510(k) NO: K021753(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD SE DECISION MADE: 06-AUG-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: EBI DYNAFIX VS OSTEOTOMY SYSTEM
EBI, L.P. 510(k) NO: K021749(TRADITIONAL)
ATTN: JON CAPARETTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K022319(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
EBI, L.P. 510(k) NO: K022419(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS PIEZON MASTER 600
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K022328(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 13-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS SELECTA DUET
ELLEX MEDICAL PTY. LTD. 510(k) NO: K021550(TRADITIONAL)
ATTN: BILL SWAIM PHONE NO : 952-881-9100
7138 SHADY OAK ROAD SE DECISION MADE: 09-AUG-02
MINNEAPOLIS, MN 55344 510(k) STATEMENT
DEVICE: UNI KNEE
ENCORE MEDICAL, L.P. 510(k) NO: K022437(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 23-AUG-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS FLEXTIP BLADE
ENDIUS, INC. 510(k) NO: K022578(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 23-AUG-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
ENTIFIC MEDICAL SYSTEMS, INC. 510(k) NO: K021837(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 30-AUG-02
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMENT RESTRICTOR, SMALL AND LARGE
EXACTECH, INC. 510(k) NO: K021765(TRADITIONAL)
ATTN: GARY MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-AUG-02
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 96 CHANNEL EEG HEADBOX MODEL EMU96
EXCEL TECH. LTD. 510(k) NO: K021599(TRADITIONAL)
ATTN: JOHN MUNFORD PHONE NO : 905 829 5300 351
2568 BRISTOL CIRCLE SE DECISION MADE: 13-AUG-02
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERPESELECT 2 ELISA IGG, MODEL ELO920G
FOCUS TECHNOLOGIES, INC. 510(k) NO: K021486(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 01-AUG-02
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFEPRO SAFETY SYRINGE
FORMOSA MEDICAL DEVICES, INC. 510(k) NO: K022063(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 972-365-8188
11497 COLUMBIA PARK DRIVE WEST SE DECISION MADE: 29-AUG-02
SUITE #9 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32258
DEVICE: FONIX, MODEL 7000
FRYE ELECTRONICS, INC. 510(k) NO: K022510(ABBREVIATED)
ATTN: KRISTINA FRYE PHONE NO : 503-620-2722
9826 S.W. TIGARD ST. SE DECISION MADE: 27-AUG-02
TIGARD, OR 97223 510(k) STATEMENT
DEVICE: PRISMA SYSTEM
GAMBRO RENAL PRODUCTS 510(k) NO: K010805(ABBREVIATED)
ATTN: SUZANNE DENNIS PHONE NO : 303-542-5075
10810 W. COLLINS AVE. SE DECISION MADE: 06-AUG-02
LAKEWOOD, CO 80215 510(k) STATEMENT
DEVICE: SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K022397(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. 414 SE DECISION MADE: 22-AUG-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K022193(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 817-887-2133
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 01-AUG-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSA-CUFF, MODELS INFANT, CHILD, ADULT
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K022482(TRADITIONAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133
4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 13-AUG-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MOBILE MILLENNIUM MG SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K022240(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 06-AUG-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE WINDOWS X-RAY/MR FUSION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K022310(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-AUG-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DASH 3000/4000 PATIENT MONITOR
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K020290(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 14-AUG-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPH-LOOP LIGATING LOOP
GENZYME BIOSURGERY 510(k) NO: K022410(SPECIAL)
ATTN: KAREN K SYLVIA PHONE NO : 508-677-6448
600 AIRPORT RD. SE DECISION MADE: 20-AUG-02
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTICS SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K022362(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 490 97784
NEW INDUSTRIAL PARK SE DECISION MADE: 09-AUG-02
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: GLOVCO EBONY
GLOVCO (M) SDN. BHD. 510(k) NO: K013828(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 13-AUG-02
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
GRASS INSTRUMENT CO. 510(k) NO: K021807(TRADITIONAL)
ATTN: PETER L FULLER PHONE NO : 781-848-2970
570 LIBERTY ST. SE DECISION MADE: 29-AUG-02
BRAINTREE, MA 02185 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
GUIDANT CARDIAC SURGERY 510(k) NO: K022718(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842
3200 LAKESIDE DR. SE DECISION MADE: 28-AUG-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER
GUIDANT CORP. 510(k) NO: K021455(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-AUG-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY
GYRUS ENT L.L.C. 510(k) NO: K021777(TRADITIONAL)
ATTN: JEFFREY W COBB PHONE NO : 901-373-2673
2925 APPLING RD SE DECISION MADE: 26-AUG-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARG
HANS RUDOLPH, INC. 510(k) NO: K020759(TRADITIONAL)
ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522
7205 CENTRAL SE DECISION MADE: 13-AUG-02
KANSAS CITY, MO 64114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
HARMAC MEDICAL PRODUCTS, INC. 510(k) NO: K021916(TRADITIONAL)
ATTN: ROBERT F MORAN PHONE NO : 716-897-4500
2201 BAILEY AVE. SE DECISION MADE: 29-AUG-02
BUFFALO, NY 14211-1797 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE LIPPOROTEIN-12, MODEL 3344
HELENA LABORATORIES 510(k) NO: K022333(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 15-AUG-02
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1
HELLEN PROFESSIONAL SERVICES 510(k) NO: K020226(TRADITIONAL)
ATTN: ROBIN HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVENUE SE DECISION MADE: 22-AUG-02
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHIT
HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K022305(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 08-AUG-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K021751(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 15-AUG-02
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
HOME MEDICAL SERVICES 510(k) NO: K021472(TRADITIONAL)
ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959
9393 ACTIVITY RD., SUITE F SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
HOME MEDICAL SERVICES 510(k) NO: K021496(TRADITIONAL)
ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959
9393 ACTIVITY RD., SUITE F SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
HORIZONS INTL. CORP. 510(k) NO: K022546(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
287 MONTERREY ST. SE DECISION MADE: 12-AUG-02
P.O.BOX 7273 510(k) STATEMENT
PONCE, PR 00717
DEVICE: XIA SPINAL SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K022160(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 01-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 FEMORAL NAIL
HOWMEDICA OSTEONICS 510(k) NO: K022461(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 22-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 TIBIAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022481(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 26-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE C FEMORAL STEMS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022555(SPECIAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 26-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULCRUM
HOWTEK, INC. 510(k) NO: K021949(TRADITIONAL)
ATTN: W. SCOTT PARR PHONE NO : 603-882-5200
21 PARK AVE. SE DECISION MADE: 12-AUG-02
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LES
HYCARE INTL. CO., LTD. 510(k) NO: K022530(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-9550
198 AVE. DE LA D'EMERALD SE DECISION MADE: 26-AUG-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHERZ
I.Z.I. CORP. 510(k) NO: K022074(TRADITIONAL)
ATTN: HELEN ZINREICH PHONE NO : 410-594-9403
7020 TUDSBURY ROAD SE DECISION MADE: 13-AUG-02
BALTIMORE, MD 21244 510(k) STATEMENT
DEVICE: HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
IMPLEX CORP. 510(k) NO: K022563(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 30-AUG-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROBOOT
INCAPPE, INC. 510(k) NO: K022233(TRADITIONAL)
ATTN: ROBERT SHERIDAN PHONE NO : 910-509-0403
632 DUNDEE DRIVE SE DECISION MADE: 12-AUG-02
WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
INDUS TEXTILES, INC. 510(k) NO: K013958(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 19-AUG-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
INNOVATIVE GLOVES CO; LTD 510(k) NO: K021668(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 447 4730
500 M004, T. KUANLUNG, HATYAI, SE DECISION MADE: 12-AUG-02
SONGKHLA, THAILAND 90110 510(k) STATEMENT
DEVICE: POLY-CARB
INOVATIV, LLC 510(k) NO: K022030(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 503-585-4362
1155 TWIN HILLS DRIVE SE DECISION MADE: 28-AUG-02
JEFFERSON, OR 97352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETAL
INOVATIV, LLC 510(k) NO: K022032(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 503-585-4362
1155 TWIN HILLS DRIVE SE DECISION MADE: 29-AUG-02
JEFFERSON, OR 97352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAMATIC AT-400
INSTRUMENTATION LABORATORY CO. 510(k) NO: K022195(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 07-AUG-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K022550(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 27-AUG-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILAYER MATRIX WOUND DRESSING
INTEGRA LIFESCIENCES CORP. 510(k) NO: K021792(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-275-0500
311C ENTERPRISE DRIVE SE DECISION MADE: 14-AUG-02
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC
INTEGRA NEUROSCIENCES 510(k) NO: K022553(SPECIAL)
ATTN: NANCY A MATHEWSON PHONE NO : 858-622-2737
5955 PACIFIC CENTER BLVD. SE DECISION MADE: 20-AUG-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
INTEGRA NEUROSCIENCES 510(k) NO: K022554(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DRIVE SE DECISION MADE: 23-AUG-02
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE S
INTERPORE CROSS INTL. 510(k) NO: K022348(SPECIAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
INTERVASCULAR 510(k) NO: K022242(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-431-7240
20 WALNUT ST. SE DECISION MADE: 14-AUG-02
SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA
WELLESLEY, MA 02481
DEVICE: FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
ISOLATION SYSTEMS, INC. 510(k) NO: K022260(TRADITIONAL)
ATTN: TED ULATOWSKI PHONE NO : 716-694-6390
79 FILLMORE AVE. SE DECISION MADE: 29-AUG-02
TONAWANDA, NY 14150-2335 510(k) STATEMENT
DEVICE: SR IVOCRON
IVOCLAR VIVADENT, INC. 510(k) NO: K013869(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 28-AUG-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JENSEN GOLD FOIL
JENSEN INDUSTRIES, INC. 510(k) NO: K022206(TRADITIONAL)
ATTN: JOHN SLANSKI PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 29-AUG-02
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY HS-CRP CONTROLS
KAMIYA BIOMEDICAL CO. 510(k) NO: K022486(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 14-AUG-02
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: MODULITH SLK LITHOTRIPTER
KARL STORZ ENDOSCOPY 510(k) NO: K011700(TRADITIONAL)
ATTN: JENNIFER S PORTUGAL PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 16-AUG-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA QUADRO SWITCH
KARL STORZ ENDOSCOPY 510(k) NO: K021776(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 15-AUG-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLO
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022101(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 02-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER E
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022102(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 22-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022347(TRADITIONAL)
ATTN: TEOH CHOH SHEE PHONE NO : 605 891 1111
PT. 5054, P.O. BOX 9 SE DECISION MADE: 15-AUG-02
KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
TAIPING, PERAK, MALAYSIA 34600
DEVICE: MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVE
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022548(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 15-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WS-501 HEAT LAMP
LHASA MEDICAL, INC. 510(k) NO: K013197(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1071
234 LIBBEY PKWY. SE DECISION MADE: 29-AUG-02
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K021819(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 23-AUG-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
LIGHTMED CORP. 510(k) NO: K021538(TRADITIONAL)
ATTN: IRENE LIN PHONE NO : 886 2 26764920
NO.1-1, LANE1,PAO-AN ST. SEC.3 SE DECISION MADE: 08-AUG-02
SHULIN CITY, CHINA (TAIWAN) 238 510(k) STATEMENT
DEVICE: CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K021887(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER RD., SUITE 340 SE DECISION MADE: 15-AUG-02
SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LODOX, MODEL BASELINE
LODOX SYSTEMS (PTY) LTD. 510(k) NO: K013999(TRADITIONAL)
ATTN: BRADLEY SACKS PHONE NO : 212-439-0746
177 EAST 79TH STREET SE DECISION MADE: 06-AUG-02
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10021
DEVICE: APL IGA ELISA KIT
LOUISVILLE APL DIAGNOSTICS, INC. 510(k) NO: K021398(TRADITIONAL)
ATTN: SILVIA S PIERANGELI PHONE NO : 770-455-7129
3988 FLOWERS RD., SUITE 620 SE DECISION MADE: 27-AUG-02
DORAVILLE, GA 30360 510(k) STATEMENT
DEVICE: CERANUM 87
LUCIUS METALS COM. 510(k) NO: K021947(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 562-799-6626
4241 FARQUHAR AVE. #2 SE DECISION MADE: 26-AUG-02
LOS ALAMITOS, CA 90720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERACAM
LUMALITE, INC. 510(k) NO: K021083(TRADITIONAL)
ATTN: W. EDWARD JOHANSEN PHONE NO : 310-826-4902
11661 SAN VICENTE BOULEVARD SE DECISION MADE: 30-AUG-02
LOS ANGELES, CA 90049 510(k) STATEMENT
DEVICE: BCLEAR
LUMENIS, INC. 510(k) NO: K021762(TRADITIONAL)
ATTN: C. ROBERT PAYNE, JR. PHONE NO : 925-249-8031
1249 QUARRY LN., SUITE 100 SE DECISION MADE: 23-AUG-02
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAEDA SILVER ACUPUNCTURE NEEDLE
MAEDA TOYOKICHI SHOTEN 510(k) NO: K021904(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 14-AUG-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
MAGLY ORTHOPEDICS, LLC 510(k) NO: K021579(TRADITIONAL)
ATTN: DAVE STINSON PHONE NO : 425-489-2057
15009 NE 195TH STREET SE DECISION MADE: 09-AUG-02
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGLY 6.5MM CANNULATED SCREWS
MAGLY ORTHOPEDICS, LLC 510(k) NO: K021662(TRADITIONAL)
ATTN: DAVE STINSON PHONE NO : 425-489-2057
14241 NE WOODINVILLE-DUVALL RD SE DECISION MADE: 12-AUG-02
#415 510(k) SUMMARY AVAILABLE FROM FDA
WOODINVILLE, WA 98072
DEVICE: STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENT
MAXXIM MEDICAL 510(k) NO: K021452(TRADITIONAL)
ATTN: JULIO GONZALEZ PHONE NO : 727-556-6152
4750 118TH AVE NORTH SE DECISION MADE: 01-AUG-02
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDAMICUS AXIA RSN
MEDAMICUS, INC. 510(k) NO: K022689(SPECIAL)
ATTN: KARYL HASKELL PHONE NO : 763-559-2613
15301 HWY. 55 WEST SE DECISION MADE: 23-AUG-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
MEDCOMP 510(k) NO: K021759(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 27-AUG-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T SCANMED PV ARRAY
MEDIC, INC. 510(k) NO: K022395(SPECIAL)
ATTN: RANDALL W JONES PHONE NO : 402-571-3271
6912 NORTH 97TH CIRCLE, SE DECISION MADE: 13-AUG-02
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
OMAHA, NE 68122
DEVICE: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWA
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K022568(SPECIAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 29-AUG-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASC
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K022569(SPECIAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 29-AUG-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
MEDIPLUS LTD. 510(k) NO: K013704(TRADITIONAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-535-1247
541 MORENO CIRCLE NE SE DECISION MADE: 05-AUG-02
ST. PETERSBURG, FL 33703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
MEDRAD, INC. 510(k) NO: K021988(ABBREVIATED)
ATTN: LORRAINE R FREDES PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 29-AUG-02
INDIANOLA, PA 15051 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021791(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-344-1124
1800 PYRAMID PLACE SE DECISION MADE: 26-AUG-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K022191(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-AUG-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K022414(SPECIAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 14-AUG-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM;
MEDTRONIC, INC. 510(k) NO: K021804(TRADITIONAL)
ATTN: JULIE GOODE PHONE NO : 763-514-7247
800 53RD AVE NE SE DECISION MADE: 28-AUG-02
MINNEAPOLIS, MN 55421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGO
MEDTRONIC, INC. 510(k) NO: K021902(TRADITIONAL)
ATTN: LUCY TAN PHONE NO : 763-391-9000
7611 NORTHLAND DRIVE SE DECISION MADE: 12-AUG-02
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7F LAUNCHER GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K022764(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 28-AUG-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY
MENNEN MEDICAL LTD. 510(k) NO: K022168(SPECIAL)
ATTN: DAVID P JOHNSON PHONE NO : 716-759-6921
10123 MAIN STREET SE DECISION MADE: 01-AUG-02
CLARENCE, NY 14031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
MEPS, LLC. 510(k) NO: K020400(TRADITIONAL)
ATTN: HARRY BENEDICT PHONE NO : 954-713-8017
ONE EAST BROWARD BLVD #700 SE DECISION MADE: 23-AUG-02
FORT LAUDERDALE, FL 33301 510(k) STATEMENT
DEVICE: ABR-2000
MERIDIAN CO., LTD. 510(k) NO: K020360(TRADITIONAL)
ATTN: SOO-RANG LEE PHONE NO : 822 210 33320
9FI SEOIL BLDG SE DECISION MADE: 29-AUG-02
222 JAMSILBON-DONG 510(k) SUMMARY AVAILABLE FROM FDA
SONGPA-GU, SEOUL, REPUBLIC OF KOREA
DEVICE: EASYTEM EAR THERMOMETER, MODEL BT-020
METATECH CO., LTD. 510(k) NO: K020520(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 06-AUG-02
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MHS MED LIGHT 1000
MICRO HEALTH SYSTEMS INC. 510(k) NO: K021956(TRADITIONAL)
ATTN: ROBERT BARNES PHONE NO : 954-575-1076
7407 DOVER LANE SE DECISION MADE: 13-AUG-02
PARKLAND, FL 33067 510(k) STATEMENT
DEVICE: MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
MILTON HODOSH, M.D. 510(k) NO: K022025(TRADITIONAL)
ATTN: MILTON HODOSH PHONE NO : 401-781-3591
243 ELWOOD AVENUE SE DECISION MADE: 15-AUG-02
PROVIDENCE, RI 02907 510(k) STATEMENT
DEVICE: MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL
MINIMED, INC. 510(k) NO: K021974(TRADITIONAL)
ATTN: GERDA RESCH PHONE NO : 818-576-4198
18000 DEVONSHIRE ST. SE DECISION MADE: 06-AUG-02
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
MLE, INC. 510(k) NO: K021834(TRADITIONAL)
ATTN: CHRISTINE E NICHOLS PHONE NO : 508-839-6122
10 GREENLAWN AVE SE DECISION MADE: 28-AUG-02
S. GRAFTON, MA 01560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
MPW INDUSTRIAL WATER SERVICES, INC510(k) NO: K001755(ABBREVIATED)
ATTN: BILL WATSON PHONE NO : 330-273-8494
2848 INTERSTATE PARKWAY SE DECISION MADE: 05-AUG-02
BRUNSWICK, OH 44212 510(k) STATEMENT
DEVICE: ISA-21 INTERVENTIONAL SPINE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K021631(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 13-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HRH-127-8 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022372(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 13-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022487(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 23-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODEL OBC-63 BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022488(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 23-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NANMA ADJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K013051(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 22-AUG-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: CERALOY
NEIRYNCK & VOGT NV 510(k) NO: K021971(TRADITIONAL)
ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945
12960 STONECREEK DRIVE SE DECISION MADE: 01-AUG-02
PICKERINGTON, OH 43147 510(k) STATEMENT
DEVICE: 800 SERIES EASYNEB NEBULIZER
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K020357(TRADITIONAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 07-AUG-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALLU PLATES
NEWDEAL S.A. 510(k) NO: K021626(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 12-AUG-02
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINET
NICOLET BIOMEDICAL, INC. 510(k) NO: K021986(TRADITIONAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 23-AUG-02
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPERMASSIST
NIDACON INTERNATIONAL AB 510(k) NO: K022443(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 28-AUG-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXLINE CLAMP
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K010727(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-3640
200 GREGORY LANE SE DECISION MADE: 09-AUG-02
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: RF TENT
ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K022157(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010
P.O. BOX 548 SE DECISION MADE: 28-AUG-02
YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSS-28CS-301/701 NEEDLESCOPE
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013759(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 20-AUG-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K022270(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 14-AUG-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
OPHTHALMED LLC 510(k) NO: K021696(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 20-AUG-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUSDUO EC DENTAL LASER SYSTEM
OPUSDENT LTD. 510(k) NO: K021508(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 9 7718130
117 AHUZAH ST. SE DECISION MADE: 07-AUG-02
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOBAG, MODEL CB
ORIGEN BIOMEDICAL, INC. 510(k) NO: K021702(TRADITIONAL)
ATTN: RICHARD MARTIN PHONE NO : 512-474-7278
9709-A BECK CIRCLE SE DECISION MADE: 06-AUG-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AVALON CUP SYSTEM
ORTHOPEDIC SOURCE INC. 510(k) NO: K022711(SPECIAL)
ATTN: STEVEN M MANDELL PHONE NO : 800-500-0381
5975 HORSESHOE BAR ROAD SE DECISION MADE: 26-AUG-02
P.O. BOX 307 510(k) SUMMARY AVAILABLE FROM FDA
LOOMIS, CA 95650
DEVICE: NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
ORTHOSOFT, INC. 510(k) NO: K021760(TRADITIONAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 27-AUG-02
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3A DENTAL IMPLANT SYSTEM
OSSECO BIOSOURCE, LTD 510(k) NO: K011879(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O.BOX 848 SE DECISION MADE: 27-AUG-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL MANDIBULAR DISTRACTION SYSTEM
OSTEOMED CORP. 510(k) NO: K013618(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 14-AUG-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSA RIGID INTERNAL FIXATION SYSTEM
OSTEOMED CORP. 510(k) NO: K021618(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 08-AUG-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED BONE TRANSPORT DISTRACTION DEVICE
OSTEOMEDICS, INC. 510(k) NO: K021341(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 01-AUG-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
OSTEOMEDICS, INC. 510(k) NO: K021342(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 01-AUG-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAI
P.T. HEALTHCARE GLOVINDO 510(k) NO: K021659(TRADITIONAL)
ATTN: ELLEN HUTAPEA PHONE NO : 626 168 50017
JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 12-AUG-02
KAWASAN INDUSRI MEDAN 510(k) STATEMENT
MEDAN, INDONESIA 10340
DEVICE: PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
PALL MEDICAL 510(k) NO: K013093(TRADITIONAL)
ATTN: LEONARD S BERMAN PHONE NO : 516-484-5400
600 S. WAGNER RD. SE DECISION MADE: 01-AUG-02
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIBAND
PAW, LLC 510(k) NO: K022404(TRADITIONAL)
ATTN: ANDREW J WHELAN PHONE NO : 301-682-4795
5540 HIDDEN WATERS LANE SE DECISION MADE: 08-AUG-02
FREDERICK, MD 21703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIONOMER
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K022150(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 21-AUG-02
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
PENTRON CORP. 510(k) NO: K021457(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD SE DECISION MADE: 01-AUG-02
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: CHITO-SEAL
PERCLOSE, INC. 510(k) NO: K021062(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164
400 SAGINAW DRIVE SE DECISION MADE: 23-AUG-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
PERSONAL PRODUCTS CO., DIV. OF MCN510(k) NO: K021492(TRADITIONAL)
ATTN: MARYLOU PANICO PHONE NO : 908-904-3709
199 GRANDVIEW RD. SE DECISION MADE: 07-AUG-02
SKILLMAN, NJ 08558-9418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE V
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K022601(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 26-AUG-02
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: PHILIPS BABY THERMOMETER SET (SBC SC530)
PHILIPS CONSUMER ELECTRONICS 510(k) NO: K022542(TRADITIONAL)
ATTN: BOB POOLER PHONE NO : 865-521-4701
ONE PHILIPS DRIVE SE DECISION MADE: 20-AUG-02
KNOXVILLE, TN 37914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERF (OMMAYA STYLE) RESERVOIRS
PHOENIX BIOMEDICAL CORP. 510(k) NO: K021644(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 06-AUG-02
P.O. BOX 80390 510(k) STATEMENT
VALLEY FORGE, PA 19484
DEVICE: PTS PANELS MULTI-CHEMISTRY CONTROLS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K022401(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 21-AUG-02
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
POLYSTAN A/S 510(k) NO: K013038(TRADITIONAL)
ATTN: DANA OLSEN PHONE NO : 454 465 1566
WALGERHOLM 8 SE DECISION MADE: 14-AUG-02
VAERLOSE, DENMARK DK-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
POLYSTAN A/S 510(k) NO: K022281(TRADITIONAL)
ATTN: DANA OLSEN PHONE NO : 45 44 651566
WALGERHOLM 8 SE DECISION MADE: 06-AUG-02
VAERLOSE, DENMARK DK-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
POREX SURGICAL, INC. 510(k) NO: K021357(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 05-AUG-02
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
PRAXIM 510(k) NO: K022239(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS
PRECISION SYSTEMS, INC. 510(k) NO: K022072(TRADITIONAL)
ATTN: BILL HADEN PHONE NO : 508-655-7010
16 TECH CIRCLE SE DECISION MADE: 23-AUG-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
PT. MAJA AGUNG LATEXINDO 510(k) NO: K020040(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIEL STREET SE DECISION MADE: 01-AUG-02
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION P
PURITAN-BENNETT 510(k) NO: K021573(SPECIAL)
ATTN: GINA TO PHONE NO : 925-463-4427
2200 FARADAY AVENUE SE DECISION MADE: 13-AUG-02
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
QUALIGEN, INC. 510(k) NO: K021972(TRADITIONAL)
ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 21-AUG-02
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE
QUANTEL MEDICAL 510(k) NO: K021650(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 16-AUG-02
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIPID CONTROL
RANDOX LABORATORIES, LTD. 510(k) NO: K022591(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 30-AUG-02
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: MULTI FUCTIONAL REHABILITATION CHAIR
RAYE'S, INC. 510(k) NO: K022407(TRADITIONAL)
ATTN: WILLARD LEE FRICKEY PHONE NO : 800-537-6454
204 WEST 2ND ST. SE DECISION MADE: 16-AUG-02
ELLIS, KS 67637 510(k) STATEMENT
DEVICE: DISPO MULTI (METHAFILCON A) SOFT (HYDROPILIC) MULTIFOCAL LENS FO
REGULATORY INSIGHT, INC. 510(k) NO: K021720(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 12-AUG-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-
REHABILICARE, INC. 510(k) NO: K022405(SPECIAL)
ATTN: EDWARD F VALDEZ PHONE NO : 651-638-0448
1811 OLD HIGHWAY 8 SE DECISION MADE: 12-AUG-02
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOPULSE RESUSCITATION SYSTEM
REVIVANT CORP. 510(k) NO: K022345(SPECIAL)
ATTN: SUSANNE T SMITH PHONE NO : 408-524-3500
775 PALOMAR AVE. SE DECISION MADE: 15-AUG-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHIGENE MESACUP-2 TEST RNP, MODEL M7741
RHIGENE, INC. 510(k) NO: K022017(TRADITIONAL)
ATTN: YUSUKE KOBE PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 14-AUG-02
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: ELECSYS ANTI-TG TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020672(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 05-AUG-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
ROCHE DIAGNOSTICS CORP. 510(k) NO: K022654(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 29-AUG-02
PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q4
ROSSMAX INTERNATIONL LTD. 510(k) NO: K020897(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 06-AUG-02
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: RUSCH EDGAR TUBE
RUSCH INTL. 510(k) NO: K021540(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
TALL PINES PARK SE DECISION MADE: 01-AUG-02
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIM 16 AUTOCLAVE
SCICAN 510(k) NO: K021064(TRADITIONAL)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797
1440 DON MILLS RD. SE DECISION MADE: 08-AUG-02
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE S
SENORX, INC. 510(k) NO: K021707(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 14-AUG-02
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALGUT
SERRAL, S.A. DE C.V. 510(k) NO: K020597(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 14-AUG-02
PALM HARBOR,, FL 34685 510(k) STATEMENT
DEVICE: DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE W
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K021853(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 011 862 157814213
259 YUSHU RD., SE DECISION MADE: 01-AUG-02
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA 201600
DEVICE: 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022337(SPECIAL)
ATTN: AMY SHAW HOSLER PHONE NO : 732-321-4830
186 WOOD AVENUE SOUTH SE DECISION MADE: 13-AUG-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANA
SIGMA DIAGNOSTICS, INC. 510(k) NO: K021162(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 30-AUG-02
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
SINTEA BIOTECH, INC. 510(k) NO: K022065(TRADITIONAL)
ATTN: MARIANNE GRUNWALDT PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 06-AUG-02
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL KNEE FEMORAL COMPONENT
SMITH & NEPHEW, INC. 510(k) NO: K022010(SPECIAL)
ATTN: KIM KELLY PHONE NO : 800-821-5700
1450 E. BROOKS ROAD SE DECISION MADE: 19-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATION
SMITH & NEPHEW, INC. 510(k) NO: K022460(SPECIAL)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 E. BROOKS ROAD SE DECISION MADE: 19-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION MODIFIED ACETABULAR SHELLS
SMITH & NEPHEW, INC. 510(k) NO: K022556(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 28-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-REL
SOOIL DEVELOPMENT CO., LTD. 510(k) NO: K022317(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 02-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMOS SYSTEM
SPACELABS MEDICAL, INC. 510(k) NO: K013046(TRADITIONAL)
ATTN: EDWARD M BASILE PHONE NO : 202-626-2903
1730 PENNSYLVANIA AVE. NW SE DECISION MADE: 21-AUG-02
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESCAPE CONTROL MODULE
SPECIALTY DRIVES TECHNOLOGIES, INC510(k) NO: K021995(TRADITIONAL)
ATTN: SCOTT KERSEY PHONE NO : 770-363-7398
509 PLEASANT HILL CHURCH RD. SE DECISION MADE: 01-AUG-02
WINDER, GA 30680 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTITUDE CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K021719(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 15-AUG-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K022218(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 12-AUG-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINE VISION, INC 510(k) NO: K021507(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD SE DECISION MADE: 01-AUG-02
15TH FLOOR SUITE 1500 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: UNI-T UNI-THREAD SPINAL SYSTEM
SPINE VISION, INC 510(k) NO: K021510(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 404-460-5075
3003 SUMMIT BLVD SE DECISION MADE: 01-AUG-02
15TH FLOOR SUITE 1500 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: CONTOURED ATCULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYST
STD MFG., INC. 510(k) NO: K021549(TRADITIONAL)
ATTN: STEVE EK PHONE NO : 781-828-4400
1063 TURNPIKE ST. SE DECISION MADE: 01-AUG-02
P.O. BOX 420 510(k) SUMMARY AVAILABLE FROM FDA
STOUGHTON, MA 02072
DEVICE: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
STERILMED, INC. 510(k) NO: K012523(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-AUG-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
STERILMED, INC. 510(k) NO: K012678(TRADITIONAL)
ATTN: PATICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-AUG-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER L3 HYDROLERT
STRYKER ENDOSCOPY 510(k) NO: K022248(TRADITIONAL)
ATTN: MICHAEL HILLDOERFER PHONE NO : 408-754-2664
5900 OPTICAL CT. SE DECISION MADE: 06-AUG-02
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONESOURCE HAC
STRYKER INSTRUMENTS 510(k) NO: K021440(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 616-323-4226
4100 EAST MILHAM AVENUE SE DECISION MADE: 02-AUG-02
KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYK
STRYKER INSTRUMENTS 510(k) NO: K022162(SPECIAL)
ATTN: DANNIELLE WHEELER PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 01-AUG-02
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOSYSTEM/NT, MODEL 80-13020
STYKER INSTRUMENTS 510(k) NO: K020320(TRADITIONAL)
ATTN: KELLI BITTERBURG PHONE NO : 877-534-2464
4100 EAST MILHAM AVE. SE DECISION MADE: 28-AUG-02
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
SULZER ORTHOPEDICS, INC. 510(k) NO: K021578(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306
9900 SPECTRUM DR. SE DECISION MADE: 09-AUG-02
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
SUNI IMAGING MICROSYSTEMS, INC. 510(k) NO: K021718(TRADITIONAL)
ATTN: F. AL BETTENCOURT PHONE NO : 408-227-6698
6840 VIA DEL ORO, SUITE 10 SE DECISION MADE: 15-AUG-02
SAN JOSE, CA 95119 510(k) STATEMENT
DEVICE: DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
SURGICON, INC. 510(k) NO: K021747(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203-380-8771
400 LONG BEACH BLVD. SE DECISION MADE: 15-AUG-02
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
SYMMETRY MEDICAL, INC. 510(k) NO: K012105(TRADITIONAL)
ATTN: D. DARIN MARTIN PHONE NO : 219-268-2252
220 WEST MARKET SE DECISION MADE: 02-AUG-02
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
SYNERGETICS, INC. 510(k) NO: K020220(TRADITIONAL)
ATTN: SUE OSTER PHONE NO : 636-939-5100
88 HUBBLE DR. SE DECISION MADE: 23-AUG-02
ST. CHARLES, MO 63304-8694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
SYNTHES (USA) 510(k) NO: K021556(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 09-AUG-02
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES CRANIOFACIAL PLATES
SYNTHES (USA) 510(k) NO: K021642(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 14-AUG-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPT OPEN ACCESS PORT, MODEL 41233
TAUT, INC. 510(k) NO: K021731(TRADITIONAL)
ATTN: MAX CLOAT PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 08-AUG-02
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
TENSYS MEDICAL, INC. 510(k) NO: K020537(TRADITIONAL)
ATTN: STUART L GALLANT PHONE NO : 858-552-1941
5825 OBERLIN DRIVE SE DECISION MADE: 15-AUG-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: MININEPH HUMAN B2-MICROGLOBULIN KIT
THE BINDING SITE, LTD. 510(k) NO: K014270(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 15-AUG-02
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
THE ELECTRIC STORE 510(k) NO: K022197(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540
936-11TH AVENUE EAST SE DECISION MADE: 13-AUG-02
SEATTLE, WA 98102 510(k) STATEMENT
DEVICE: MODIFICATION TO RELIEF BRIEF
THE JM KOHN CO. 510(k) NO: K003128(TRADITIONAL)
ATTN: CHARLES L MORIN PHONE NO : 415-957-0101
201 SPEAR STREET SE DECISION MADE: 12-AUG-02
SUITE 1600 510(k) SUMMARY AVAILABLE FROM FDA
SAN FRANCISCO, CA 94105-1635
DEVICE: TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE MEDICAL (THAILAND) CO., 510(k) NO: K021950(TRADITIONAL)
ATTN: AUDIE SEOW PHONE NO : 66 74 412913
NO 58 MOO 7 KARNCHANAWANICH RD SE DECISION MADE: 01-AUG-02
PRIK, SADAO 510(k) STATEMENT
SONGKHLA, THAILAND 90120
DEVICE: TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELL
TOP GLOVE SDN. BHD. 510(k) NO: K021855(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 603 339 21992
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 05-AUG-02
OFF JALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA
DEVICE: SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K022400(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 06-AUG-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
TOTOKU ELECTRIC CO., LTD 510(k) NO: K021738(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 011 812 68345484
300 OYA, UEDA-SHI, SE DECISION MADE: 19-AUG-02
NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSONIC FLOW-QC SET MODEL ADT1010
TRANSONIC SYSTEMS, INC. 510(k) NO: K021571(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300
34 DUTCH MILL RD. SE DECISION MADE: 12-AUG-02
ITHACA, NY 14850-9787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAGUIDE CTG 2000SA
ULTRAGUIDE LTD. 510(k) NO: K022354(SPECIAL)
ATTN: GEORGE MYERS PHONE NO :
377 ROUTE 17 SOUTH SE DECISION MADE: 13-AUG-02
HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOFLEX MESH
UNICARE BIOMEDICAL, INC. 510(k) NO: K021511(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707
25951 LA CUESTA AVE. SE DECISION MADE: 06-AUG-02
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UKNEE TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP. 510(k) NO: K021657(TRADITIONAL)
ATTN: PHILIP LEUNG PHONE NO : 886 356 63351
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 12-AUG-02
HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012687(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-327-8680
5307 GREAT OAK DR. SE DECISION MADE: 01-AUG-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURE-LOK
VITAL SIGNS, INC. 510(k) NO: K021315(ABBREVIATED)
ATTN: THOMAS W DIELMANN PHONE NO : 303-790-4835
11039 EAST LANSING CIRCLE SE DECISION MADE: 21-AUG-02
ENGLEWOOD, CO 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE PRESSURE MANOMETER
VITAL SIGNS, INC. 510(k) NO: K022402(TRADITIONAL)
ATTN: DAVID L NAJJAR PHONE NO : 973-790-1330
20 CAMPUS ROAD SE DECISION MADE: 22-AUG-02
TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCLIP
VMBC, LLC 510(k) NO: K021745(TRADITIONAL)
ATTN: DAVID ELLIOT, JR. PHONE NO : 651-482-8451
3600 LABORE ROAD SE DECISION MADE: 20-AUG-02
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
WHITE BEAR LAKE, MN 55110
DEVICE: REGISTRADO X-TRA
VOCO GMBH 510(k) NO: K022066(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 14-AUG-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: LASER FIBER GF500
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K021686(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 20-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
WECK 510(k) NO: K021808(TRADITIONAL)
ATTN: JAMES LUCKY PHONE NO : 919-361-1401
2917 WECK DR. SE DECISION MADE: 14-AUG-02
DURHAM, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K022453(SPECIAL)
ATTN: DON M ABBEY PHONE NO : 503-530-7500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 21-AUG-02
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATIO
WILSHIRE TECHNOLOGIES 510(k) NO: K022095(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 09-AUG-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ER150/M2
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K021456(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 01-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K021717(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 20-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DB1 EMBRYO FREEZE
ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K011327(TRADITIONAL)
ATTN: FRED ZANDER PHONE NO : 561-569-5955
755 8TH CT., SUITE #4 SE DECISION MADE: 15-AUG-02
P.O.650790 510(k) SUMMARY AVAILABLE FROM FDA
VERO BEACH, FL 32962
TOTAL 510(k)s THIS PERIOD 336
TOTAL WITH SUMMARIES 260
TOTAL WITH STATEMENTS 76
-
-