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510(k)s Final Decisions Rendered for May 2002 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAY-2002 THROUGH 31-MAY-2002
DEVICE: OCO DENTAL IMPLANT
"O" CO., INC. 510(k) NO: K021460(SPECIAL)
ATTN: DAVID D DALISE PHONE NO : 505-293-0025
600 PAISANO, N.E., SUITE A SE DECISION MADE: 22-MAY-02
ALBUQUERQUE, NM 87123 510(k) STATEMENT
DEVICE: 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
3T MEDICAL SYSTEMS, LLC. 510(k) NO: K020365(TRADITIONAL)
ATTN: ROBERT P EATON PHONE NO : 303-838-2407
12553 S. WAMBLEE VALLEY ROAD SE DECISION MADE: 03-MAY-02
CONIFER, CO 80433-6204 510(k) STATEMENT
DEVICE: AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
AALTO SCIENTIFIC LTD. 510(k) NO: K020618(TRADITIONAL)
ATTN: KENNETH GAUTHIER PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 14-MAY-02
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, A
AARON MEDICAL INDUSTRIES 510(k) NO: K020579(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 13-MAY-02
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH SILVER CONVENTIONAL
AB ARDENT 510(k) NO: K020452(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVENUE SE DECISION MADE: 07-MAY-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
ABBOTT LABORATORIES 510(k) NO: K021350(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
D-389, BLDG. J-45 SE DECISION MADE: 14-MAY-02
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: HEART PACK D
ACCESS CARDIOSYSTEMS, INC. 510(k) NO: K011461(TRADITIONAL)
ATTN: DAVID BARASH PHONE NO : 978-371-4985
150 BAKER AVENUE EXTENSION SE DECISION MADE: 28-MAY-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - T
ACCUMETRICS, INC. 510(k) NO: K013596(TRADITIONAL)
ATTN: RHONDA MOE PHONE NO : 858-404-8238
3985 SORRENTO VALLEY BLVD SE DECISION MADE: 16-MAY-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE HA SCREW DENTAL IMPLANT SYSTEM
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K021244(SPECIAL)
ATTN: J EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL ST. SE DECISION MADE: 03-MAY-02
BROCKTON, MA 02301 510(k) STATEMENT
DEVICE: SIB CATHETER, MODEL 61-7005
ACKRAD LABORATORIES 510(k) NO: K021272(SPECIAL)
ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6390
70 JACKSON DR. SE DECISION MADE: 21-MAY-02
CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
ACMI-CIRCON CORPORATION 510(k) NO: K021166(SPECIAL)
ATTN: JOHN A DELUCIA PHONE NO : 508-804-2617
136 TURPIKE RD SE DECISION MADE: 09-MAY-02
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE S
ACON LABORATORIES CO. 510(k) NO: K020313(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 08-MAY-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON ONE STEP DRUG SCREEN TEST CARD
ACON LABORATORIES, INC. 510(k) NO: K020771(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 15-MAY-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
ACTHERM, INC. 510(k) NO: K021612(SPECIAL)
ATTN: RICHARD HSIEH PHONE NO : 886 355 37315
6TH F, NO 85 SE DECISION MADE: 30-MAY-02
KUAN-MIN 6 ROAD JUBEI 302 510(k) STATEMENT
HSINCHU, CHINA (TAIWAN)
DEVICE: DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
ACTHERM, INC. 510(k) NO: K021614(SPECIAL)
ATTN: RICHARD HSIEH PHONE NO : 886 355 37319
6TH F, NO 85 SE DECISION MADE: 30-MAY-02
KUAN-MIN 6 ROAD JUBEI 302 510(k) STATEMENT
HSINCHU, CHINA (TAIWAN)
DEVICE: AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
ADVANCED DIAGNOSTICS, INC. 510(k) NO: K013886(TRADITIONAL)
ATTN: STEVE HESSLER PHONE NO : 425-222-7169
8112 304TH AVE. SE SE DECISION MADE: 10-MAY-02
PRESTON, WA 98050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
AEROGEN, INC. 510(k) NO: K021175(TRADITIONAL)
ATTN: TRACI V. A EDWARDS PHONE NO : 408-543-2414
1310 ORLEANS DR. SE DECISION MADE: 15-MAY-02
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K021447(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377ROUTE 17 S SE DECISION MADE: 22-MAY-02
HASBROUCK HEIGHT, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIDLOCK 195 ADHESIVE
ALLODEX SYSTEMS 510(k) NO: K020648(TRADITIONAL)
ATTN: MELVYN A STEINBERG PHONE NO : 888-820-5836
10195 EAST WETHERSFIELD RD. SE DECISION MADE: 01-MAY-02
SCOTTSDALE, AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SPARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K021263(SPECIAL)
ATTN: MARK MCINTYRE PHONE NO : 952-930-6120
10700 BREN RD., WEST SE DECISION MADE: 15-MAY-02
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R
ANIMAS CORP. 510(k) NO: K021439(SPECIAL)
ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990
590 E. LANCASTER AVENUE SE DECISION MADE: 29-MAY-02
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
APL PRODUCTS SDN. BHD. 510(k) NO: K020865(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 605 672 3152
LOT 8961 & 8964 SE DECISION MADE: 08-MAY-02
JALAN BERUAS 510(k) STATEMENT
AYER TAWAR,PERAK DARUL RIDZUAN, MALAYSIA 32400
DEVICE: COLORQUICK STREP A TEST
APPLIED BIOTECH, INC. 510(k) NO: K021375(SPECIAL)
ATTN: STEVE WORCESTER PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 21-MAY-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: COLORQUICK STREP A (II) TEST
APPLIED BIOTECH, INC. 510(k) NO: K021406(SPECIAL)
ATTN: STEVE WORCESTER PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 21-MAY-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: APPLIED URETERAL CATHETER
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K020577(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6120
22872 AVENIDA EMPRESSA SE DECISION MADE: 22-MAY-02
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AROMACRYL
AROMACRYL, LLC 510(k) NO: K021121(TRADITIONAL)
ATTN: TANYA L WOODS PHONE NO : 248-544-0860
1013 EAST THIRD STREET SE DECISION MADE: 28-MAY-02
ROYAL OAK, MI 48067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,
ARROW INTL., INC. 510(k) NO: K021120(SPECIAL)
ATTN: DEBBIE PEACOCK PHONE NO : 610-378-1031
2400 BERNVILLE RD. SE DECISION MADE: 02-MAY-02
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWE
ARTHROCARE CORP. 510(k) NO: K020408(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 02-MAY-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENTEC PLASMA WANDS
ARTHROCARE CORP. 510(k) NO: K021364(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 30-MAY-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON
ATRIUM MEDICAL CORP. 510(k) NO: K020634(SPECIAL)
ATTN: JOSEPH P DE PAOLA PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 08-MAY-02
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STAN
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K020348(TRADITIONAL)
ATTN: EILEEN A MCCAFFERTY PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 02-MAY-02
LUNA PLACE 510(k) STATEMENT
DUNDEE, SCOTLAND, UNITED KINGDOM DD2 1XA
DEVICE: ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K020349(TRADITIONAL)
ATTN: EILEEN A MCCAFFERTY PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 02-MAY-02
LUNA PLACE 510(k) STATEMENT
DUNDEE, SCOTLAND, UNITED KINGDOM DD2 1XA
DEVICE: DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K020687(TRADITIONAL)
ATTN: EILEEN MCCAFFERTY PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 02-MAY-02
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) STATEMENT
DEVICE: BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
BABIES BEST, INC. 510(k) NO: K013587(TRADITIONAL)
ATTN: JAY SALKIN PHONE NO : 323-587-3009
3825 SOUTH SANTE FE AVE. SE DECISION MADE: 14-MAY-02
VERNON, CA 90058-1712 510(k) STATEMENT
DEVICE: THE NURTURE III BREAST PUMP
BAILEY MEDICAL ENGINEERING 510(k) NO: K020375(TRADITIONAL)
ATTN: BARRY BAILEY PHONE NO : 805-528-5781
2216 SUNSET DR. SE DECISION MADE: 03-MAY-02
LOS OSOS, CA 93402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED C
BAUSCH & LOMB 510(k) NO: K020927(TRADITIONAL)
ATTN: DEBRA L. B KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 16-MAY-02
ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
BAUSCH & LOMB INCORPORATED 510(k) NO: K020802(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 585-338-8172
1400 N. GOODMAN STREET SE DECISION MADE: 31-MAY-02
ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS
BAXTER HEALTHCARE CORP. 510(k) NO: K021274(TRADITIONAL)
ATTN: VIVKI L DREWS PHONE NO : 847-270-5916
RT. 120 AND WILSON ROAD SE DECISION MADE: 17-MAY-02
ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC
BAYLIS MEDICAL CO., INC. 510(k) NO: K020354(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DR. #33 SE DECISION MADE: 03-MAY-02
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT
DEVICE: ISOSEEDS I-125
BEBIG ISOTOPEN-UND MEDIZINTECHNIK 510(k) NO: K021343(TRADITIONAL)
ATTN: SVEN LANGER PHONE NO : 49 30 947084
ROBERT-ROSSLE STR 10 SE DECISION MADE: 20-MAY-02
BERLIN, GERMANY D-131125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERTAPENEM 10UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K020842(TRADITIONAL)
ATTN: MICHELLE BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 15-MAY-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K020321(TRADITIONAL)
ATTN: BRADFORD M SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 23-MAY-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-LOGIC ABAER CUB
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K021215(SPECIAL)
ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326
ONE BIO-LOGIC PLAZA SE DECISION MADE: 15-MAY-02
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,
BIO-RAD 510(k) NO: K021384(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 29-MAY-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461,
BIO-RAD 510(k) NO: K021411(TRADITIONAL)
ATTN: ELIZABETH PLATE PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 29-MAY-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW
BIO-RAD 510(k) NO: K021414(TRADITIONAL)
ATTN: ELIZABETH PLATE PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 29-MAY-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW
BIO-RAD 510(k) NO: K021415(TRADITIONAL)
ATTN: ELIZABETH PLATE PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 29-MAY-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
BIO-RAD 510(k) NO: K021498(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO ROAD SE DECISION MADE: 24-MAY-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WIT
BIO-SCAN S.A 510(k) NO: K013897(ABBREVIATED)
ATTN: RICHARD M SANO PHONE NO : 917-424-0330
153 SANFORD LANE SE DECISION MADE: 21-MAY-02
STAMFORD, CT 06905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G4 SLEEVED NAIL
BIOMET MANUFACTURING, INC. 510(k) NO: K020962(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 24-MAY-02
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDABLE KNEE
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020381(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 06-MAY-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LAT
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K021403(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 31-MAY-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
BIOMET, INC. 510(k) NO: K021182(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 13-MAY-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSS LES PROXIMAL FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K021380(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 BELL DRIVE SE DECISION MADE: 28-MAY-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CURELLE, PREFERRED CURELLE, CUTEQ 2.5
BIOTEQUE AMERICA, INC. 510(k) NO: K020628(TRADITIONAL)
ATTN: DENIS DORSEY PHONE NO : 215-750-8071
340 EAST MAPLE AVE., #204-C SE DECISION MADE: 24-MAY-02
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
BIOTRONIK, INC. 510(k) NO: K021217(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 01-MAY-02
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVEA
BIRD PRODUCTS CORP. 510(k) NO: K013642(TRADITIONAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 22-MAY-02
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORION NASAL CPAP SYSTEM
BIRD PRODUCTS CORP. 510(k) NO: K020730(SPECIAL)
ATTN: TOM GUITERREZ PHONE NO : 760-778-7200
1100 BIRD CENTER DR. SE DECISION MADE: 22-MAY-02
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
BLACKSTONE MEDICAL, INC. 510(k) NO: K020600(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 22-MAY-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WA
BLACKSTONE MEDICAL, INC. 510(k) NO: K020620(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 23-MAY-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM
BOEHRINGER LABORATORIES 510(k) NO: K020538(TRADITIONAL)
ATTN: CHRISTOPHER RADL PHONE NO : 610-278-0900
500 E. WASHINGTON STREET SE DECISION MADE: 15-MAY-02
NORRISTOWN, PA 19401 510(k) STATEMENT
DEVICE: CONSTELLATION CATHETERS, MODEL 8031M
BOSTON SCIENTIFIC CORP. 510(k) NO: K021232(SPECIAL)
ATTN: CHRISTINA L ROWE PHONE NO : 408-895-3526
2710 ORCHARD PARKWAY SE DECISION MADE: 16-MAY-02
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDWELLING FECAL MANAGEMENT SYSTEM
BOWEL MANAGEMENT SYSTEMS, LLC 510(k) NO: K012113(TRADITIONAL)
ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916
7992 CASTEWAY DRIVE SE DECISION MADE: 03-MAY-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX SURGEONS GLOVE (POWDERED)
BRIGHTWAY GLOVES PVT. LTD. 510(k) NO: K014278(TRADITIONAL)
ATTN: N. PARAMASIVAN PHONE NO : 91 465 2276291
PIONEER MANIKANDAN BUILDINGS SE DECISION MADE: 14-MAY-02
VADASERY, NAGAR COIL 510(k) SUMMARY AVAILABLE FROM FDA
TAMIL NADU, INDIA 629001
DEVICE: LATEX SURGEONS GLOVE (POWDER FREE)
BRIGHTWAY GLOVES PVT. LTD. 510(k) NO: K014283(TRADITIONAL)
ATTN: N. PARAMASIVAN PHONE NO : 91 465 2276291
PIONEER MANIKANDAN BUILDINGS SE DECISION MADE: 22-MAY-02
VADASERY, NAGAR COIL 510(k) SUMMARY AVAILABLE FROM FDA
TAMIL NADU, INDIA 629001
DEVICE: IRRIGATING CANNULA
CA GUARD, LTD. 510(k) NO: K020614(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 24-MAY-02
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET CRONO H
CANE S.R.I. 510(k) NO: K013855(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 09-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET CRONO PCA
CANE SRL 510(k) NO: K013822(TRADITIONAL)
ATTN: DANIEL KAMM, PE PHONE NO : 847-347-1727
P.O. BOX 7007 SE DECISION MADE: 08-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET CRONO PAR AND CRONO APO-GO
CANE SRL 510(k) NO: K013840(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 14-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMAGEN V3.0 RATE OF READING ENHANCEMENT SOFT CONTACT LENS
CANTOR & NISSEL LTD. 510(k) NO: K012132(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 09-MAY-02
GRAND JUCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
CARDIONOW, INC. 510(k) NO: K020449(TRADITIONAL)
ATTN: JOHNNY M GARZA PHONE NO : 760-633-9797
535 ENCINITAS BLVD., SUITE 118 SE DECISION MADE: 10-MAY-02
ENCINITAS, CA 92024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECT STIM
CARE REHAB AND ORTHOPAEDIC 510(k) NO: K020637(TRADITIONAL)
ATTN: CHRISTIAN HUNT PHONE NO : 703-448-9644
1124 DOMINION CT. SE DECISION MADE: 28-MAY-02
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE IFC PLUS
CARE REHAB, INC. 510(k) NO: K020516(TRADITIONAL)
ATTN: CHRISTIAN E HUNT PHONE NO : 703-448-9644
1124 DOMINION COURT SE DECISION MADE: 16-MAY-02
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APATIGHT HA-BONE GRAFT SUBSTITUTE
CERABIO, LLC 510(k) NO: K013960(TRADITIONAL)
ATTN: JAMES J CASSIDY PHONE NO : 715-262-5451
N4660 1165TH ST. SE DECISION MADE: 23-MAY-02
PRESCOTT, WI 54021-7644 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APATIGHT-TCP BONE GRAFT SUBSTITUTE
CERABIO, LLC 510(k) NO: K013966(TRADITIONAL)
ATTN: JAMES J CASSIDY PHONE NO : 715-262-5451
N4660 1165TH ST. SE DECISION MADE: 16-MAY-02
PRESCOTT, WI 54021-7644 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QACA IGG/IGM ELISA KIT HRP
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K021192(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 441 513 488023
7 ELM ST. SE DECISION MADE: 16-MAY-02
ELLESMERE PORT, UNITED KINGDOM CH6510(k) STATEMENT
DEVICE: MODIFICATION TO 30" EXTENSION SET
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K021395(SPECIAL)
ATTN: KEVIN PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 13-MAY-02
DOVER, NH 03820 510(k) STATEMENT
DEVICE: DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-63
CLASS A ENT. 510(k) NO: K021118(SPECIAL)
ATTN: SAMANTHA L DRAPER PHONE NO : 760-956-7851
P.O. BOX 401964-16039 SE DECISION MADE: 28-MAY-02
SUITE C 510(k) STATEMENT
HESPERIA, CA 92345
DEVICE: CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORI
CODONICS, INC. 510(k) NO: K021054(TRADITIONAL)
ATTN: RICK DAYTON PHONE NO : 440-243-1198
17991 ENGLEWOOD DRIVE SE DECISION MADE: 09-MAY-02
MIDDLEBURG HEIGHTS, OH 44130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, M
COLLINS MEDICAL, INC. 510(k) NO: K011344(ABBREVIATED)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 17-MAY-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SS MATRIX
COOK BIOTECH, INC. 510(k) NO: K020732(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 30-MAY-02
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WI
CORDIS NEUROVASCULAR, INC. 510(k) NO: K021591(SPECIAL)
ATTN: MARITZA CELAYA PHONE NO : 786-313-6546
14000 N.W. 57TH CT. SE DECISION MADE: 22-MAY-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH AMPIC
DADE BEHRING, , INC. 510(k) NO: K020398(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 16-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 VANCOMYCIN ASSAY
DADE BEHRING, , INC. 510(k) NO: K020692(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 10-MAY-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION ALDL CALIBRATOR, MODEL DC131
DADE BEHRING, INC. 510(k) NO: K020723(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 08-MAY-02
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD
DADE BEHRING, INC. 510(k) NO: K020724(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 09-MAY-02
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
DADE BEHRING, INC. 510(k) NO: K020820(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 09-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
DADE BEHRING, INC. 510(k) NO: K020822(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 08-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 VANCOMYCIN CALIBRATORS
DADE BEHRING, INC. 510(k) NO: K020845(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 08-MAY-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTREP PLUS PANEL WITH AMPICILLIN
DADE BEHRING, INC. 510(k) NO: K021037(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
DADE MICROSCAN, INC. 510(k) NO: K020627(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 06-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
DADE MICROSCAN, INC. 510(k) NO: K020937(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 06-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
DADE MICROSCAN, INC. 510(k) NO: K020939(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 17-MAY-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEAM STERILIZATION INTERGRATOR
DANA PRODUCTS, INC. 510(k) NO: K012195(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847-455-2881
7 COREY DRIVE SE DECISION MADE: 07-MAY-02
SOUTH BARINGTON, IL 60010 510(k) STATEMENT
DEVICE: STARFLOW HV
DANVILLE MATERIALS, INC. 510(k) NO: K020760(TRADITIONAL)
ATTN: CRAIG R BRUNS PHONE NO : 925-838-7940
2021 OMEGA DR. SE DECISION MADE: 03-MAY-02
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPY-50
DDC TECHNOLOGIES, INC. 510(k) NO: K020513(TRADITIONAL)
ATTN: DMITRY DONSKOY PHONE NO : 516-770-0441
2980 WAVERLY AVE. SE DECISION MADE: 16-MAY-02
OCEANSIDE, NY 11572 510(k) STATEMENT
DEVICE: NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
DENNIS R. BAILEY, DDS 510(k) NO: K020893(TRADITIONAL)
ATTN: DENNIS R BAILEY PHONE NO : 303-770-3300
7901 EAST BELLEVIEW AVENUE SE DECISION MADE: 28-MAY-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80111
DEVICE: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
DENTSPLY INTL. 510(k) NO: K021410(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 08-MAY-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
DENTSPLY INTL. 510(k) NO: K021413(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 10-MAY-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERI
DENTSPLY INTL. 510(k) NO: K021416(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 13-MAY-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
DEPUY ACROMED 510(k) NO: K021148(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 08-MAY-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILITY ANKLE REVISION PROSTHESIS
DEPUY, INC. 510(k) NO: K020541(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 20-MAY-02
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRON-PC-SL ASSAY MODEL # 151-10, 151-26
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K020816(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST SE DECISION MADE: 14-MAY-02
CHARLOTTETOWN, PE, CANADA C1E2A6 510(k) STATEMENT
DEVICE: IMMULITE 2000 SPECIFIC ALLERGENS
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K021206(TRADITIONAL)
ATTN: ROBERT M DI TULLIO PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 30-MAY-02
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: IMMULITE 2000 MIXED ALLERGEN PANELS
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K021208(TRADITIONAL)
ATTN: ROBERT M DI TULLIO PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 30-MAY-02
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: AXSYM INTACT PTH, MODEL 2G06
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K020945(TRADITIONAL)
ATTN: CARROLL POTTS PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD. SE DECISION MADE: 31-MAY-02
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
DIATEK, INC. 510(k) NO: K020430(TRADITIONAL)
ATTN: JON WILSON PHONE NO : 336-725-9711
101 N. CHESTNUT ST. SE DECISION MADE: 09-MAY-02
WINSTON-SALEM, NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K021324(SPECIAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
3 HASADNOAT ST. SE DECISION MADE: 23-MAY-02
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOKE EVACUATION HOSES/TUBING
DM MEDICAL INC. 510(k) NO: K020510(TRADITIONAL)
ATTN: ROBERT W MAYS PHONE NO : 800-884-6414
10865 MILLINGTON CT. SE DECISION MADE: 03-MAY-02
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
DUKAL CORP. 510(k) NO: K020726(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 727-376-9105
3234 ELLA LANE SE DECISION MADE: 15-MAY-02
NEW PORT RICHE, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI AIS SPINE SYSTEM
EBI, L.P. 510(k) NO: K020887(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-MAY-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX RAIL SYSTEM
EBI, L.P. 510(k) NO: K021031(TRADITIONAL)
ATTN: MICHAEL T TAGGART PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-MAY-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K021091(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 03-MAY-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI DFS OPTIROM ELBOW FIXATOR
EBI, L.P. 510(k) NO: K021312(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 23-MAY-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DM SLEEVE
EMILY IKER M.D., A.P.C. 510(k) NO: K021102(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET SE DECISION MADE: 08-MAY-02
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTERYX INJECTOR
ENTERIC MEDICAL TECHNOLOGIES 510(k) NO: K013712(TRADITIONAL)
ATTN: JILL M VISOR PHONE NO : 650-574-2867
551 FOSTER CITY BLVD. SE DECISION MADE: 31-MAY-02
SUITE G 510(k) STATEMENT
FOSTER CITY, CA 94404
DEVICE: FINESUN EMS STIMULATOR
FINESUN WORLDWIDE INTL. CO., LTD. 510(k) NO: K020684(TRADITIONAL)
ATTN: CHI-CHU WU CHEN PHONE NO : 886 3 5785853
3F, NO.31, HU-PIN ROAD #1 SE DECISION MADE: 23-MAY-02
SCIENCE BASED INDUSTRIAL PARK 510(k) STATEMENT
HSIN-CHU, CHINA (TAIWAN) 300
DEVICE: ESOP HA FEMORAL STEM
FOURNITURES HOSPITALIERES 510(k) NO: K021108(SPECIAL)
ATTN: ANDRE WEITH PHONE NO : 202-835-1346
C/O PHARMANET, INC. SE DECISION MADE: 03-MAY-02
815 CONNECTICUT AVE NW STE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: FUJIREBIO DIAGNOSTICS CA 19-9 RIA
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K020566(TRADITIONAL)
ATTN: DANIEL J O'SHANNESSY PHONE NO : 610-240-3811
201 GREAT VALLEY PARKWAY SE DECISION MADE: 09-MAY-02
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC ELITE CEMENT 100
GC AMERICA, INC. 510(k) NO: K021038(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 03-MAY-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K021135(SPECIAL)
ATTN: JOELLE NEIDER PHONE NO : 203-949-8232
61 BARNES PARK ROAD NORTH SE DECISION MADE: 09-MAY-02
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K021435(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 817-887-2133
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 22-MAY-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HISPEED CT/E DUAL COMPUTED TOMOGRAPHY SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K021491(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 22-MAY-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNITY IS PATIENT VIEWER
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K020661(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 24-MAY-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF APEXPRO TELEMETRY SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K021325(SPECIAL)
ATTN: JOELLE NEIDER PHONE NO : 203-949-8232
8200 WEST TOWER AVE. SE DECISION MADE: 07-MAY-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
GERM TERMINATOR CORPORATION 510(k) NO: K021258(TRADITIONAL)
ATTN: DAVID LINK PHONE NO : 978-371-0066
100 MAIN STREET, SE DECISION MADE: 10-MAY-02
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742 THIRD PARTY REVIEW
DEVICE: GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K020341(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 4 9097784
NEW INDUSTRIAL PARK SE DECISION MADE: 02-MAY-02
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
GLOVCO (M) SDN. BHD. 510(k) NO: K021308(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 14-MAY-02
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: SYNCRUS INTERNAL CARDIOVERSION SYSTEM
GUIDANT CARDIAC SURGERY 510(k) NO: K020701(TRADITIONAL)
ATTN: DEBBIE COGAN PHONE NO : 408-845-1910
3200 LAKESIDE DR. SE DECISION MADE: 24-MAY-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BA
GUIDANT CORP. 510(k) NO: K021228(SPECIAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 909-914-4581
26531 YNEZ RD. SE DECISION MADE: 15-MAY-02
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LV-1 HEMOSTASIS VALVE, MODEL #6789
GUIDANT CORP. 510(k) NO: K021282(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-MAY-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDANT BALLOON CATHETER, SEVERAL MODELS
GUIDANT CORP. 510(k) NO: K021283(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-MAY-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYTRAK GUIDING CATHETER
GUIDANT CORP. 510(k) NO: K021284(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-MAY-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE EXTRA S'PORT GUIDEWIRE
GUIDANT CORP. 510(k) NO: K021285(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-MAY-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
GYRUS ENT L.L.C. 510(k) NO: K020778(TRADITIONAL)
ATTN: JEFFERY W COBB PHONE NO : 901-373-2673
2925 APPLING RD SE DECISION MADE: 28-MAY-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALESTER
H & A CONSULTANTS 510(k) NO: K020902(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 20-MAY-02
PALM HARBOR, FL 34685 510(k) STATEMENT
DEVICE: MICRO-INDUCTION 1000 SYSTEM
HARBINGER MEDICAL, INC. 510(k) NO: K013615(TRADITIONAL)
ATTN: HAROLD HOIUM PHONE NO : 952-944-2302
12086 OXBOW DRIVE SE DECISION MADE: 29-MAY-02
EDEN PRAIRE, MN 55347 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-SCOPE AN & EZ-SCOPE AN LITE
HEALTH POLICY RESORTERS GROUP, LLC510(k) NO: K020643(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
2305 GOLDMINE ROAD SE DECISION MADE: 28-MAY-02
ROCKVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K021479(SPECIAL)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 21-MAY-02
AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
HELENA LABORATORIES 510(k) NO: K020625(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 06-MAY-02
BEAUMONT, TX 77704 510(k) STATEMENT
DEVICE: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
HELENA LABORATORIES 510(k) NO: K020914(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 23-MAY-02
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: QFLOW 500 PERFUSION MONITORING SYSTEM
HEMEDEX 510(k) NO: K013376(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 08-MAY-02
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INRATIO
HEMOSENSE, INC. 510(k) NO: K020679(TRADITIONAL)
ATTN: JUDITH BLUNT PHONE NO : 408-719-1393
600 VALLEY WAY SE DECISION MADE: 06-MAY-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERNIAMESH T-SLING
HERNIAMESH 510(k) NO: K020652(TRADITIONAL)
ATTN: LORENA TRABUCCO PHONE NO : 516-938-3042
8 ORANGE DR., SE DECISION MADE: 15-MAY-02
JERICHO, NY 11753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIVOX EAR THERMOMETER, TS SERIES
HIVOX BIOTEK, INC. 510(k) NO: K020471(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 225 168488
12F, NO.156, SEC.1,CHIEN KUO SE DECISION MADE: 02-MAY-02
NORTH RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 104
DEVICE: T2 ARTHRODESIS NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020384(TRADITIONAL)
ATTN: WILLIAM J CYMBALUK PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 06-MAY-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STE
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020615(SPECIAL)
ATTN: WILLIAM J CYMBALUK PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 13-MAY-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
HOWMEDICA OSTEONICS CORP. 510(k) NO: K021310(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379
59 ROUTE 17 SE DECISION MADE: 21-MAY-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT PROTHROMBIN TIME TEST
I-STAT CORPORATION 510(k) NO: K020355(TRADITIONAL)
ATTN: PAUL VANDERERF PHONE NO : 609-443-9300
104 WINDSOR CENTER DRIVE SE DECISION MADE: 14-MAY-02
EAST WINDSOR, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDM97
IBP INSTRUMENTS GMBH 510(k) NO: K020908(TRADITIONAL)
ATTN: WERNER PFINGSTMANN PHONE NO : 495 116 51647
SUTELSTR. 7A SE DECISION MADE: 22-MAY-02
HANNOVER, GERMANY 30659 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HDM99
IBP INSTRUMENTS GMBH 510(k) NO: K020909(TRADITIONAL)
ATTN: WERNER PFINGSTMANN PHONE NO : 459 116 51647
SUTELSTR. 7A SE DECISION MADE: 22-MAY-02
HANNOVER, GERMANY 30659 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
ID BIOMEDICAL CORP. 510(k) NO: K020576(TRADITIONAL)
ATTN: DAVID CLARY PHONE NO : 425-482-2601
19204 N. CREEK PKWAY., STE 100 SE DECISION MADE: 01-MAY-02
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCTEIA 25-HYDROXY VITAMIN D
IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K021163(TRADITIONAL)
ATTN: PAUL PUNTIN PHONE NO : 441 915 190660
10 DIDCOT WAY SE DECISION MADE: 10-MAY-02
BOLDON BUSINESS PARK 510(k) STATEMENT
BOLDON, TYNE & WEAR, UNITED KINGDOTHIRD PARTY REVIEW
DEVICE: OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
IMPLANT INNOVATIONS, INC. 510(k) NO: K014235(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-776-6913
4555 RIVERSIDE DR. SE DECISION MADE: 16-MAY-02
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YY
IMPLEX CORP. 510(k) NO: K021025(SPECIAL)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 20-MAY-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
INDUSTRIAL CLOTHINGS, LTD. 510(k) NO: K021465(TRADITIONAL)
ATTN: UMAIR AHMED PHONE NO : 94 1 437575
481A, PRINCE OF WALES AVE. SE DECISION MADE: 22-MAY-02
COLOMBO 14, SRI LANKA 510(k) STATEMENT
DEVICE: LIGHTLANCE LASER SKIN PERFORATOR
INNOTECH USA, INC. 510(k) NO: K013021(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813
COLUMBIA SQUARE SE DECISION MADE: 30-MAY-02
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC, DC
DEVICE: HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL
INSTRUMENTATION LABORATORY CO. 510(k) NO: K021022(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 14-MAY-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNAS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K021023(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 14-MAY-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL HIGH ABNORMAL CONTROL (ASSAYED); HEMOSIL HIGH ABNORMAL C
INSTRUMENTATION LABORATORY CO. 510(k) NO: K021024(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 16-MAY-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K021323(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 22-MAY-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: OCULIGHT SL/SLX
IRIDEX CORP. 510(k) NO: K020374(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 03-MAY-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX 800 LASER SYSTEM, MODEL APEX 800
IRIDEX CORP. 510(k) NO: K020849(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 20-MAY-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRC POSTEC
IVOCLAR VIVADENT, INC. 510(k) NO: K013802(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 01-MAY-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CARBON POST
J. MORITA USA, INC. 510(k) NO: K012496(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 17-MAY-02
WASHINGTON, DC 20005 510(k) STATEMENT
DEVICE: JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
JOMED CATHETER, INC. 510(k) NO: K021088(SPECIAL)
ATTN: NORMAN L HALL PHONE NO : 518-792-2183
604 QUEENSBURY AVE. SE DECISION MADE: 02-MAY-02
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: SMARTWIRE/SMARTMAP PRESSURE SYSTEM
JOMED, INC. 510(k) NO: K021219(SPECIAL)
ATTN: TERRY SCHULTZ PHONE NO : 858-673-0189
2870 KILGORE RD. SE DECISION MADE: 17-MAY-02
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA SCB MEDIA CONTROL
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K020640(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE 5TH FLOOR SE DECISION MADE: 28-MAY-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
KINAMED, INC. 510(k) NO: K013982(TRADITIONAL)
ATTN: VINEET SARIN PHONE NO : 805-384-2748
820 FLYNN ROAD SE DECISION MADE: 21-MAY-02
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: WET CHAMBER
KINETIC CONCEPTS, INC. 510(k) NO: K020781(TRADITIONAL)
ATTN: JUITH A HARBOUR PHONE NO : 210-255-4468
P.O. BOX 659508 SE DECISION MADE: 06-MAY-02
SAN ANTONIO, TX 78265-9508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K020554(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 03-MAY-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
KLIMAMED TECHNOLOGIE MEDIZINGERATE510(k) NO: K011859(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-429-8180
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 01-MAY-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020254(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER ROAD SUITE 340 SE DECISION MADE: 10-MAY-02
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KI
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020763(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER RD., SUITE 340 SE DECISION MADE: 10-MAY-02
SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-LOADED BIOSTINGER HORNET
LINVATEC CORP. 510(k) NO: K020377(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 06-MAY-02
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
LS RUBBER SDN BHD 510(k) NO: K020633(ABBREVIATED)
ATTN: MARIZA MARZIH PHONE NO : 607 599 3923
PLO 22,SENAI INDUSTRIAL ESTATE SE DECISION MADE: 15-MAY-02
PHASE 1 510(k) SUMMARY AVAILABLE FROM FDA
SENAI, JOHOR, MALAYSIA 81400
DEVICE: BCLEAR
LUMENIS 510(k) NO: K020591(TRADITIONAL)
ATTN: C. ROBERT PAYNE JR. PHONE NO : 925-249-8031
1249 QUARRY LANE SE DECISION MADE: 16-MAY-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94566-3403
DEVICE: DUOPRO SAFETY SYRINGE (DUOPROSS)
M.K. MEDITECH CO. LTD. 510(k) NO: K020623(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 02-MAY-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX INTRAMEDULLARY NAIL SYSTEM
MAGLY ORTHOPEDICS, LLC 510(k) NO: K020562(TRADITIONAL)
ATTN: DAVE STINSON PHONE NO : 425-489-2057
15009 NE 195TH STREET SE DECISION MADE: 16-MAY-02
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
MAGNA-LAB, INC. 510(k) NO: K020993(TRADITIONAL)
ATTN: JOHN GEISEL PHONE NO : 781-246-4774
SIX KIMBALL LANE SE DECISION MADE: 21-MAY-02
SUITE 210 510(k) SUMMARY AVAILABLE FROM FDA
LYNNFIELD, MA 01940
DEVICE: ACCOMMODATOR WHEELCHAIR, MODEL #2000X
MARKEN INTERNATIONAL, INC. 510(k) NO: K021145(TRADITIONAL)
ATTN: STEVE RIFFEL PHONE NO : 406-522-8560
851 BRIDGER STR. SE DECISION MADE: 16-MAY-02
SUITE 1 510(k) STATEMENT
BOZEMAN, MT 59715
DEVICE: MASTER & FRANK SURGICAL DRAPES (STERILE)
MASTER & FRANK ENTERPRSES CO.LTD. 510(k) NO: K020393(TRADITIONAL)
ATTN: FRANK WU PHONE NO : 886 223 255066
15F-1 NO 57 SEC 2 SE DECISION MADE: 03-MAY-02
TUN HWA SOUTH RD 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN)
DEVICE: MEDAMICUS AXIA RSN
MEDAMICUS, INC. 510(k) NO: K020563(TRADITIONAL)
ATTN: KARYL D HASKELL PHONE NO : 763-577-2257
15301 HWY. 55 WEST SE DECISION MADE: 21-MAY-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
MEDCOMP 510(k) NO: K020315(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 24-MAY-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP ASH SPLIT-CATH II
MEDCOMP 510(k) NO: K020465(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 22-MAY-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDELA "BASIC 30" AND "DOMINANT 50" SUCTION PUMPS, MODELS 037, 0
MEDELA AG 510(k) NO: K021368(TRADITIONAL)
ATTN: RERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 4 SE DECISION MADE: 15-MAY-02
CH-6340 BAAR, SWITZERLAND 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
MEDEX, INC. 510(k) NO: K020780(ABBREVIATED)
ATTN: BARBARA LAW PHONE NO : 614-889-2220
6250 SHIER RINGS RD. SE DECISION MADE: 20-MAY-02
DUBLIN, OH 43016 510(k) STATEMENT
DEVICE: COMPRESSIBLE LIMB SLEEVE
MEDICAL DEVICE SERVICES, INC. 510(k) NO: K012979(TRADITIONAL)
ATTN: RON EAMES PHONE NO : 435-652-3073
144 WEST BRIGHAM RD. BLDG. E SE DECISION MADE: 08-MAY-02
ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EN-SNARE ENDOVASCULAR SNARE AND CATHETER
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K021606(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 S.W. 47TH AVE. SE DECISION MADE: 31-MAY-02
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VEN
MEDICAL INSTRUMENTS TECHNOLOGY, IN510(k) NO: K012614(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 435-674-4010
385 NORTH 3050 EAST, SUITE B SE DECISION MADE: 01-MAY-02
ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-STRESS ECHO BED
MEDICAL POSITIONING, INC. 510(k) NO: K021171(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 08-MAY-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTI ST#1 SILICONE PESSARY
MEDICAL TECHNOLOGY AND INNOVATIONS510(k) NO: K020512(TRADITIONAL)
ATTN: LARRY W JAMES PHONE NO : 816-525-6677
1072 N.W. HIGH POINT DRIVE SE DECISION MADE: 16-MAY-02
LEE'S SUMMIT, MO 64081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERDICT-II PROPOXYPHENE
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K020787(TRADITIONAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 800-334-1116
1238 ANTHONY RD. SE DECISION MADE: 02-MAY-02
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 5
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K021287(SPECIAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9100
7611 NORTHLAND DR. SE DECISION MADE: 07-MAY-02
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K020709(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-MAY-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021226(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 13-MAY-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K020699(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-MAY-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K021106(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 03-MAY-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z3 GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K021256(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 17-MAY-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
MEDTRONIC, INC. 510(k) NO: K021587(SPECIAL)
ATTN: KAREN REIDT PHONE NO : 763-514-3914
7000 CENTRAL AVENUE, N.E. SE DECISION MADE: 30-MAY-02
MINNEAPOLIS, MN 55440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
MEDTRONIC, INC. 510(k) NO: K021589(SPECIAL)
ATTN: KAREN REIDT PHONE NO : 763-514-3914
7000 CENTRAL AVE. N.E. SE DECISION MADE: 30-MAY-02
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
MENICON CO. LTD. 510(k) NO: K020930(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888
269A BALLARDVALE STREET SE DECISION MADE: 02-MAY-02
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEC 1000
METRO MEDICAL EQUIPMENT, INC. 510(k) NO: K020466(TRADITIONAL)
ATTN: PAUL MOCUR PHONE NO : 734-522-8400
12985 WAYNE RD. SE DECISION MADE: 08-MAY-02
LIVONIA, MI 48150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
MICROTEK MEDICAL, INC. 510(k) NO: K020956(TRADITIONAL)
ATTN: THOMAS BONNER PHONE NO : 662-327-1863
602 LEHMBERG RD. SE DECISION MADE: 16-MAY-02
COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
MILLENIUM BIOLOGIX, INC. 510(k) NO: K011726(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE SE DECISION MADE: 16-MAY-02
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: FIXATION (STEINMANN) PINS
MILTEX, INC. 510(k) NO: K013888(TRADITIONAL)
ATTN: RICHARD GORDON PHONE NO : 516-576-6022
700 HICKSVILLE RD. SE DECISION MADE: 01-MAY-02
BETHPAGE, NY 11714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INPATH E2 COLLECTOR
MOLECULAR DIAGNOSTICS 510(k) NO: K013258(TRADITIONAL)
ATTN: ROBERT L HABIG PHONE NO : 312-222-9550
414 N. ORLEANS SE DECISION MADE: 31-MAY-02
SUITE 510 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60610
DEVICE: Y.E.S 10 WHEELCHAIR
MOVINGPEOPLE.NET 510(k) NO: K021255(TRADITIONAL)
ATTN: PEGGY SPILIADIS PHONE NO : 416 739 8333
500 NORTINCH DRIVE SE DECISION MADE: 02-MAY-02
TORONTO, ONTARIO, CANADA M3N 1Y4 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K013053(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 09-MAY-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K021090(SPECIAL)
ATTN: GINA TO PHONE NO : 925-436-4427
4280 HACIENDA DR. SE DECISION MADE: 08-MAY-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K021577(SPECIAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 29-MAY-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N2000 BASE STATION; N2001 NURSE STATION
NEPTEC DESIGN GROUP, LTD. 510(k) NO: K020584(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLEN LANE SE DECISION MADE: 22-MAY-02
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TST - SUPPRESSOR MODEL #1000
NEUROSIM LIMITED 510(k) NO: K013827(TRADITIONAL)
ATTN: IAN BROWN PHONE NO : 039 894 4555
13 FUCHSIA STREET SE DECISION MADE: 21-MAY-02
BLACKBURN 3130 510(k) STATEMENT
VICTORIA, AUSTRALIA 3130
DEVICE: PULMO-MIST COMPRESSOR MODEL # 4323
NIDEK MEDICAL PRODUCTS, INC. 510(k) NO: K020797(TRADITIONAL)
ATTN: L. G SUELTER PHONE NO : 205-856-7200
3949 VALLEY EAST INDUSTRIAL DR SE DECISION MADE: 03-MAY-02
BIRMINGHAM, AL 35217 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ECHOSCAN, MODEL US-1800
NIDEK, INC. 510(k) NO: K020876(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 03-MAY-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43
NOBEL BIOCARE USA, INC. 510(k) NO: K020646(TRADITIONAL)
ATTN: VINCENT CHEUNG PHONE NO : 714-282-5074
22715 SAVI RANCH PKWY. SE DECISION MADE: 29-MAY-02
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
NORAV MEDICAL LTD. 510(k) NO: K012712(TRADITIONAL)
ATTN: STEVE SPRINGROSE PHONE NO : 763-559-4794
12505 58TH AVE. N. SE DECISION MADE: 08-MAY-02
PLYMOUTH, MN 55442 510(k) STATEMENT
DEVICE: NSI HEXED AND NON-HEXED IMPLANT SYSTEM
NSI 510(k) NO: K020617(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10565 LEE HIGHWAY SE DECISION MADE: 10-MAY-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
FAIRFAX,, VA 22030
DEVICE: MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR
NUCLETRON CORP. 510(k) NO: K021286(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 23-MAY-02
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OHMEDA MEDICAL GIRAFFE OMNIBED
OHMEDA MEDICAL 510(k) NO: K020543(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5200
8880 GORMAN RD. SE DECISION MADE: 09-MAY-02
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OHMEDA MEDICAL GIRAFFE INCUBATOR
OHMEDA MEDICAL 510(k) NO: K020547(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5204
8880 GORMAN RD. SE DECISION MADE: 09-MAY-02
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
OLYMPUS AMERICA, INC. 510(k) NO: K021073(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5000
TWO CORPORATE CENTER DR. SE DECISION MADE: 01-MAY-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
OLYMPUS AMERICA, INC. 510(k) NO: K021074(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 02-MAY-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS BF TYPE UM40
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K021204(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 01-MAY-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUICKCLOT
ON SITE GAS SYSTEMS, INC. 510(k) NO: K013390(TRADITIONAL)
ATTN: C. BURTON GULLONG PHONE NO : 860-229-2799
35 BUDNEY ROAD SE DECISION MADE: 23-MAY-02
NEWINGTON, CT 06111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.
ON SITE GAS SYSTEMS, INC. 510(k) NO: K021082(TRADITIONAL)
ATTN: C. BARTON GULLONG PHONE NO : 860-667-8888
35 BUDNEY ROAD SE DECISION MADE: 22-MAY-02
BUDNEY INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NEWINGTON,, CT 06111
DEVICE: FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC. 510(k) NO: K021105(TRADITIONAL)
ATTN: MICHAEL L SABOLINSKI PHONE NO : 781-575-0775
150 DAN RD. SE DECISION MADE: 10-MAY-02
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTAFLEX SURGICAL SLING
ORGANOGENESIS, INC. 510(k) NO: K021107(TRADITIONAL)
ATTN: MICHAEL L SABOLINSKI PHONE NO : 781-575-0775
150 DAN RD. SE DECISION MADE: 15-MAY-02
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
ORTHO DEVELOPMENT CORP. 510(k) NO: K020383(TRADITIONAL)
ATTN: CAROL FREASIER PHONE NO : 801-553-9991
12187 S. BUSINESS PARK DR. SE DECISION MADE: 06-MAY-02
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL
ORTHO TEC LLC 510(k) NO: K021379(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 31-MAY-02
CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMIX BONE GRAFT EXTENDER
OSTEOGENICS BIOMEDICAL, INC. 510(k) NO: K013764(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST DR SE DECISION MADE: 16-MAY-02
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXACARE G4
OSTEOMETER MEDITECH, INC. 510(k) NO: K021331(SPECIAL)
ATTN: RAJA KRISHNAMURTI PHONE NO : 310-349-2280
12515 CHADRON AVE. SE DECISION MADE: 21-MAY-02
HAWTHORNE, CA 90250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADPRO MODEL #2516
PADPRO LLC. 510(k) NO: K020203(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O.BOX 7007 SE DECISION MADE: 08-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADPRO, MODEL 2502
PADPRO LLC. 510(k) NO: K020743(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O.BOX 7007 SE DECISION MADE: 28-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K020453(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 10-MAY-02
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEX VALVED HOLDING CHAMBER
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K020944(TRADITIONAL)
ATTN: LAWRENCE WEINSTEIN PHONE NO : 804-639-7235
13800 HULL ST. RD. SE DECISION MADE: 09-MAY-02
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AT HOME OVULATION TEST, MODEL 9032
PHAMATECH INC. 510(k) NO: K021409(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101-106 SE DECISION MADE: 24-MAY-02
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K020752(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 616-833-2250
MUNZINGERSTRASSE 7 SE DECISION MADE: 02-MAY-02
FREIBURG, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K020757(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 761 47 805310
MUNZINGERSTRASSE 7 SE DECISION MADE: 02-MAY-02
FREIBURG, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K020758(TRADITIONAL)
ATTN: MICHARL LINSS PHONE NO : 761 47 805310
MUNZINGERSTRASSE 7 SE DECISION MADE: 02-MAY-02
FREIBURG, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS
PHILIPS LIGHTING CO. 510(k) NO: K021092(TRADITIONAL)
ATTN: TONI J HOFFMANN PHONE NO : 732-563-3000
200 FRANKLIN SQ. DR. SE DECISION MADE: 16-MAY-02
P.O. BOX 6800 510(k) SUMMARY AVAILABLE FROM FDA
SOMERSET, NJ 08875-6800
DEVICE: PHILIPS PLS9W/12/2P UVB
PHILIPS LIGHTING CO. 510(k) NO: K021514(TRADITIONAL)
ATTN: TONI J HOFFMANN PHONE NO : 732-563-3081
200 FRANKLIN SQ. DR. SE DECISION MADE: 16-MAY-02
SOMERSET, NJ 08875-6800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021251(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 07-MAY-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03,
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021300(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 08-MAY-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021347(SPECIAL)
ATTN: DENISE HALEY PHONE NO : 978-659-2701
3000 MINUTEMAN RD. MS 0490 SE DECISION MADE: 07-MAY-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021422(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 15-MAY-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
PHOTO MEDEX, , INC. 510(k) NO: K020847(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300
2431 IMPALA DR. SE DECISION MADE: 16-MAY-02
CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALILEO CAS/NAV TKR SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K020298(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 20-MAY-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SL-PLUS LATERALIZED STEM
PLUS ORTHOPEDICS 510(k) NO: K021178(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 14-MAY-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND
POLY VUE TECHNOLGIES, INC. 510(k) NO: K020608(TRADITIONAL)
ATTN: DEANNA WERBER PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 16-MAY-02
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 5
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K020719(TRADITIONAL)
ATTN: BARBARA J WHITMAN PHONE NO : 215-862-4450
4 B EAST BRIDGE ST. SE DECISION MADE: 10-MAY-02
NEW HOPE, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST FLEXSHAFT 2, MODEL FS2 14
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K021249(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 215-862-4450
110 UNION SQUARE DR. SE DECISION MADE: 15-MAY-02
NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAGARD IMPERVIOUS REINFORCED GOWN
PRECEPT MEDICAL PRODUCTS, INC. 510(k) NO: K013846(TRADITIONAL)
ATTN: MARY ANN FAULKNER PHONE NO : 828-681-0209
370 AIRPORT ROAD SE DECISION MADE: 22-MAY-02
ARDEN, NC 28704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYCOCARD CRP
PRIMUS CORP. 510(k) NO: K013787(TRADITIONAL)
ATTN: JIMMIE K NOFFSINGER PHONE NO : 816-523-7491
SE DECISION MADE: 14-MAY-02
510(k) STATEMENT
DEVICE: PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PR
PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K021065(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 91 484 421983
14 A, COCHIN SPECIAL ECONOMIC SE DECISION MADE: 08-MAY-02
ZONE 510(k) STATEMENT
KAKKANAD, COCHIN, KERALA, INDIA 682 030
DEVICE: LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET,
PRINCETON BIOMEDITECH CORP. 510(k) NO: K014192(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 23-MAY-02
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESIGN DOA 4 (THC/OPI/COC/MET)
PRINCETON BIOMEDITECH CORP. 510(k) NO: K014193(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 23-MAY-02
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS HCG SERUM/URINE
PRINCETON BIOMEDITECH CORP. 510(k) NO: K020439(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 23-MAY-02
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAINSTREAM WATER PURIFICATION DEVICE
PRISMEDICAL CORP. 510(k) NO: K012716(TRADITIONAL)
ATTN: ELAINE ALAMBRA PHONE NO : 707-258-8666
1100 TRANCAS ST., STE. 250 SE DECISION MADE: 07-MAY-02
NAPA, CA 94558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFT
PROXIMA THERAPEUTICS, INC. 510(k) NO: K011690(TRADITIONAL)
ATTN: MARTINE D SCHNEIDER PHONE NO : 770-753-4848
2555 MARCONI DRIVE, SUITE 220 SE DECISION MADE: 06-MAY-02
ALPHARETTA, GA 30005-2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSYCHEMEDICS RIA CANNABINOID ASSAY
PSYCHEMEDICS CORP. 510(k) NO: K011426(TRADITIONAL)
ATTN: WILLIAM R THISTLE PHONE NO : 617-868-7455
5832 UPLANDER WAY SE DECISION MADE: 03-MAY-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT GLAZE II
PULPDENT CORPORATION 510(k) NO: K020514(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 16-MAY-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPER
PULSION MEDICAL SYSTEMS AG 510(k) NO: K020587(TRADITIONAL)
ATTN: JAMES M DELANEY PHONE NO : 978-371-0066
100 MAIN ST. SE DECISION MADE: 23-MAY-02
STE. 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: QUICKVUE ONE-STEP HCG-URINE
QUIDEL CORP. 510(k) NO: K020799(TRADITIONAL)
ATTN: JENNIFER S HANKARD PHONE NO : 858-552-7910
10165 MCKELLAR CT. SE DECISION MADE: 17-MAY-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKVUE ONE-STEP HCG-COMBO
QUIDEL CORP. 510(k) NO: K020801(TRADITIONAL)
ATTN: JENNIFER S HANKARD PHONE NO : 858-552-7910
10165 MCKELLAR CT. SE DECISION MADE: 17-MAY-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA
RAPID DIAGNOSTICS, INC. 510(k) NO: K020716(TRADITIONAL)
ATTN: CHARLES C.F. YU PHONE NO : 650-558-0395
1429 ROLLINS RD. SE DECISION MADE: 06-MAY-02
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPI REPLACEMENT PHOTOTHERAPY LIGHTS
REPLACEMENT PARTS INDUSTRIES, INC.510(k) NO: K021531(TRADITIONAL)
ATTN: IRA LAPIDES PHONE NO : 818-882-8611
P.O. BOX 5019 SE DECISION MADE: 31-MAY-02
CHATSWORTH, CA 91313-5019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANIDAD HEALTH-UP TENS MP-73725
ROC CHINESE-EUROPEAN INDUSTRIAL RE510(k) NO: K014126(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN STREET, SE DECISION MADE: 03-MAY-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ROSE K POST GRAFT LENS
ROSE K INTERNATIONAL LTD. 510(k) NO: K013646(TRADITIONAL)
ATTN: IAN JENNINGS PHONE NO : 647 849 4463
60 ST. ANDREWS TCE SE DECISION MADE: 30-MAY-02
HAMILTON, NEW ZEALAND 510(k) STATEMENT
DEVICE: ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K021225(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 22-MAY-02
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
ROSTAM LTD. 510(k) NO: K020535(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TPK. SE DECISION MADE: 09-MAY-02
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
SAFE SHIELD CO. LTD 510(k) NO: K020053(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SE DECISION MADE: 01-MAY-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
SANQUIN BLOOD SUPPLY FOUNDATION 510(k) NO: K020823(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 14-MAY-02
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDION 6000
SELECTIVE MED COMPONENTS, INC. 510(k) NO: K020476(TRADITIONAL)
ATTN: RICHARD FISHER PHONE NO : 740-397-7838
6 MECHANIC ST. SE DECISION MADE: 03-MAY-02
MOUNT VERNON, OH 43050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
SENSIDYNE, INC. 510(k) NO: K021246(SPECIAL)
ATTN: GEORGE MASON PHONE NO : 727-530-3602
16333 BAY VISTA DR. SE DECISION MADE: 13-MAY-02
CLEARWATER, FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GL
SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K021000(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 31-MAY-02
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION
SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K021001(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 16-MAY-02
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
SMART GLOVE CORP. SDN BHD 510(k) NO: K021013(TRADITIONAL)
ATTN: NG YEW SOON PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 22-MAY-02
SEMENTA, JALAN KAPAR 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERA
SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K020642(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 24-MAY-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
SONOSITE,INC. 510(k) NO: K021628(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297
21919 30TH DRIVE SE. SE DECISION MADE: 31-MAY-02
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPECTRAL'S 2 IN 1 (TNI-MYO)
SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K020950(TRADITIONAL)
ATTN: NISAR SHAIKH PHONE NO : 416 626 3233
135-2 THE WEST MALL SE DECISION MADE: 24-MAY-02
TORONTO, ONTARIO, CANADA M9C1C2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER W
SPIRE BIOMEDICAL INC 510(k) NO: K021212(SPECIAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 17-MAY-02
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR
ST. SHINE OPTICAL CO., LTD. 510(k) NO: K020917(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 06-MAY-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: SURGE-FREE ASPIRATION ADAPTER
STAAR SURGICAL CO. 510(k) NO: K020734(TRADITIONAL)
ATTN: HERB CRANE PHONE NO : 626-303-7902
1911 WALKER AVE. SE DECISION MADE: 16-MAY-02
MONROVIA, CA 91016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGI
STEREOTAXIS, INC. 510(k) NO: K013484(TRADITIONAL)
ATTN: PETER A TAKES PHONE NO : 314-615-6964
4041 FOREST PARK BLVD. SE DECISION MADE: 02-MAY-02
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ERCP CANNULAS
STERILMED, INC. 510(k) NO: K012680(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 06-MAY-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERISHARP 3-GALLON RSDC, MODEL RSDC3G
STERILOGIC WASTE SYSTEMS, INC. 510(k) NO: K020664(TRADITIONAL)
ATTN: ERIK R SYNNESTVEDT PHONE NO : 215-914-1110
6691 PICKARD DRIVE SE DECISION MADE: 14-MAY-02
SYRACUSE, NY 13211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO CENTURY MEDIUM STERILIZER 26" X 26"
STERIS CORP. 510(k) NO: K020747(ABBREVIATED)
ATTN: LORI HALLER PHONE NO : 814-870-8559
2424 WEST 23RD ST. SE DECISION MADE: 17-MAY-02
ERIE, PA 16506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADI
STERLING MEDIVATIONS, INC. 510(k) NO: K021216(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083
66 NEPTUNE DRIVE SE DECISION MADE: 03-MAY-02
GROTON, CT 06340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY QD EASY P INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K021296(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-814-4083
66 NEPTUNE DRIVE SE DECISION MADE: 14-MAY-02
GROTON, CT 06340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY EASY ACCESS P INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K021487(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083
66 NEPTUNE DRIVE SE DECISION MADE: 17-MAY-02
GROTON, CT 06340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTIO
STERLING MEDIVATIONS, INC. 510(k) NO: K021530(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083
66 NEPTUNE DRIVE SE DECISION MADE: 21-MAY-02
GROTON, CT 06340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERNGOLD 66, MODEL #1180230
STERNGOLD 510(k) NO: K021367(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 16-MAY-02
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
STEVEN K. SUE 510(k) NO: K013687(TRADITIONAL)
ATTN: STEVEN K SUE PHONE NO : 808-949-8876
2065 S. KING STREET SE DECISION MADE: 28-MAY-02
SUITE 304 510(k) SUMMARY AVAILABLE FROM FDA
HONOLULU, HI 96826
DEVICE: EVERSTICK ORTHO
STICK TECH LTD. 510(k) NO: K021126(TRADITIONAL)
ATTN: WILLIAM TROETEL PHONE NO : 914-664-1640
80 PARKWAY WEST SE DECISION MADE: 13-MAY-02
MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULTAN SPOROX TEST VIAL, MODEL 75195
SULTAN CHEMISTS, INC. 510(k) NO: K020612(TRADITIONAL)
ATTN: CLARK SMITH PHONE NO : 201-871-1232
85 WEST FOREST AVE. SE DECISION MADE: 07-MAY-02
ENGLEWOOD, NJ 07631 510(k) STATEMENT
DEVICE: INTRACOIL SELF-EXPANDING PERIPHERAL STENT
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K021563(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018
651 CAMPUS DR. SE DECISION MADE: 31-MAY-02
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS-30 LATERAL FEMORAL STEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K020713(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306
9900 SPECTRUM DR. SE DECISION MADE: 14-MAY-02
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPX TITANIUM CEMNT RESTRICTOR
SULZER SPINE-TECH 510(k) NO: K020344(TRADITIONAL)
ATTN: ANGELA BYLAND PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 02-MAY-02
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNSPEX TECHNOLOGIES MODEL SE 02
SUNPEX TECHNOLOGY CO., LTD. 510(k) NO: K021371(ABBREVIATED)
ATTN: JUDY HSU PHONE NO : 886 522 05882
676 CHUNG HSIAO ROAD SE DECISION MADE: 16-MAY-02
CHIA YI CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROC
SURGI-VISION, INC. 510(k) NO: K020790(TRADITIONAL)
ATTN: NANCY E TAYLOR PHONE NO : 301-527-2000
20 FIRSTFIELD RD. SUITE 200 SE DECISION MADE: 21-MAY-02
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
SURGICA CORP. 510(k) NO: K020033(SPECIAL)
ATTN: LOU MATSON PHONE NO : 916-933-5056
5090 ROBERT J. MATHEWS PKWY. SE DECISION MADE: 31-MAY-02
#4 510(k) SUMMARY AVAILABLE FROM FDA
EL DORADO HILLS, CA 95762
DEVICE: REPROCESSED COMPRESSION LIMB SLEEVES
SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K012658(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E COLUMBINE DRIVE SE DECISION MADE: 14-MAY-02
PHOENIX, AZ 85032-5655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURX RF SYSTEM
SURX, INC. 510(k) NO: K020952(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 925-398-4500
2675 COLLIER CANYON RD. SE DECISION MADE: 30-MAY-02
LIVERMORE, CA 94550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO ORTHO 3
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K020502(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 01-MAY-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K020751(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3275480
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 02-MAY-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW P
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K021058(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3275480
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 14-MAY-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLA
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K021059(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 14-MAY-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTHES PILON PLATE
SYNTHES 510(k) NO: K020602(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 20-MAY-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CALCANEAL PLATE
SYNTHES (USA) 510(k) NO: K020401(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-MAY-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) AUTOMATED TACK DRIVER
SYNTHES (USA) 510(k) NO: K021382(SPECIAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 16-MAY-02
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: PPD BALLOON DILATATION CATHETER
TELEMED SYSTEMS, INC. 510(k) NO: K020379(SPECIAL)
ATTN: MICHAEL CARROLL PHONE NO : 978-567-9033
8 KANE INDUSTRIAL DRIVE SE DECISION MADE: 06-MAY-02
HUDSON, MA 01749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMA TENS XL-A1
TENS CARE LTD. 510(k) NO: K020846(TRADITIONAL)
ATTN: BERNARD J TREMAINE PHONE NO : 44 0 1619804310
76, STOCKPORT ROAD SE DECISION MADE: 21-MAY-02
TIMPERLRY, UNITED KINGDOM WA15 7SN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
THE ELECTRODE STORE, INC. 510(k) NO: K020445(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540
936-11TH AVENUE EAST SE DECISION MADE: 10-MAY-02
SEATTLE, WA 98102 510(k) STATEMENT
DEVICE: DEGOTZEN SYNCHRO
THE GOTZEN GROUP, INC. 510(k) NO: K021245(TRADITIONAL)
ATTN: DONALD R HILL PHONE NO : 973-927-3730
30 ALDEN TERRACE SE DECISION MADE: 03-MAY-02
FLANDERS, NJ 07836 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNI-PATCH ULTRASOUND COUPLING GEL
THE LUDLOW COMPANY LP 510(k) NO: K021132(TRADITIONAL)
ATTN: M. BETH RICE PHONE NO : 413-593-8266
TWO LUDLOW PARK DR. SE DECISION MADE: 15-MAY-02
CHICOPEE, MA 01022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456,
THERMO FORMA, INC. 510(k) NO: K021042(TRADITIONAL)
ATTN: RICHARD L MILLER PHONE NO : 740-373-4763
401 MILLCREEK ROAD SE DECISION MADE: 15-MAY-02
MARIETTA, OH 45750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TTI THERMOMED MODEL 1.8 INSTRUMENT
THERMOSURGERY TECHNOLOGIES, INC. 510(k) NO: K021117(SPECIAL)
ATTN: GENE R HEDIN PHONE NO : 520-628-9300
2901 W. INDIAN SCHOOL RD. SE DECISION MADE: 02-MAY-02
PHOENIX, AZ 85017-4162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSSEPTAL NEEDLE/TROCAR
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K011727(TRADITIONAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 02-MAY-02
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUELINK BIPOLAR FLOATING BALL DEVICE
TISSUELINK MEDICAL, INC. 510(k) NO: K020574(TRADITIONAL)
ATTN: VICKI S ANASTASI PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 20-MAY-02
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: TOESCO AQUA BLUE LED LIGHT CURING DEVICE
TOEI ELECTRIC CO., LTD. 510(k) NO: K021374(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 30-MAY-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K020561(SPECIAL)
ATTN: FLORIAN EISENBERGER PHONE NO : 49 89 32175830
EDISONSTRASSE 6 SE DECISION MADE: 09-MAY-02
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
TOSOH MEDICS, INC. 510(k) NO: K020489(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 800-248-6764
347 OYSTER POINT BLVD., SE DECISION MADE: 14-MAY-02
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SOUTH SAN FRANCISCO, CA 94080
DEVICE: GATIFLOXIN
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K020762(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 440-250-1665
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 09-MAY-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: CEFOTAXIME
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K020859(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 15-MAY-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K021339(TRADITIONAL)
ATTN: CYNITHIA C KNAPP PHONE NO : 440-250-1665
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 09-MAY-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: OSSIFORM
UNICARE BIOMEDICAL, INC. 510(k) NO: K020720(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707
25951 LA CUESTA AVE. SE DECISION MADE: 07-MAY-02
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
USA INSTRUMENTS, INC. 510(k) NO: K021262(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 21-MAY-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE, HELIOS OPTION
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K021268(SPECIAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3100 HANSEN WAY SE DECISION MADE: 22-MAY-02
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
VECTOR RESEARCH & DEVELOPMENT 510(k) NO: K020113(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 17-MAY-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKUPORT M1
VIBRANT HEALTH 510(k) NO: K020567(TRADITIONAL)
ATTN: STEPHEN EMOND PHONE NO : 450 526 1295
150 DES GRANDS COTEAUX SE DECISION MADE: 02-MAY-02
BEOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT
DEVICE: B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K021344(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 24-MAY-02
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SCIENTIFIC PT WITH CALCIUM
VITAL SCIENTIFIC N.V. 510(k) NO: K020840(TRADITIONAL)
ATTN: ISRAEL M STEIN PHONE NO : 617-527-9933
ONE GATEWAY CENTER SUITE 411 SE DECISION MADE: 15-MAY-02
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 1
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K014068(TRADITIONAL)
ATTN: RALF BENDA PHONE NO : 436 274 62360
53 IGNAZ-GLAZER-STRASSE SE DECISION MADE: 03-MAY-02
BUERMOOS, AUSTRIA 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
WALTER LORENZ SURGICAL, INC. 510(k) NO: K021522(SPECIAL)
ATTN: SHERYL MALMBERG PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 21-MAY-02
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
WAVE FORM MFG., INC. 510(k) NO: K020673(TRADITIONAL)
ATTN: JOE D BROWN PHONE NO : 850-233-5512
8317 FRONT BEACH ROAD SE DECISION MADE: 30-MAY-02
SUITE 21 510(k) SUMMARY AVAILABLE FROM FDA
PANAMA CITY BEACH, FL 32407
DEVICE: SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
WHITESIDE BIOMECHANICS, INC. 510(k) NO: K012800(TRADITIONAL)
ATTN: DEBRA MEYER PHONE NO : 314-996-8540
12634 OLIVE BLVD. SE DECISION MADE: 03-MAY-02
ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGINE H.E. PRESS DESIGN-CERAMIC
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K020774(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 072 3137050
SCHWENNINGER STRABE 13 SE DECISION MADE: 22-MAY-02
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTALLOY 54
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K021242(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 16-MAY-02
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK ZILVER BILIARY STENT
WILSON-COOK MEDICAL, INC. 510(k) NO: K020788(SPECIAL)
ATTN: MARGARET J POSNER PHONE NO : 336-744-0157
4900 BETHANIA STATION ROAD SE DECISION MADE: 08-MAY-02
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVE
WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K020867(TRADITIONAL)
ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579
426 MAIN ST. NORTH SE DECISION MADE: 20-MAY-02
P.O. BOX 505 510(k) STATEMENT
WOODBURY, CT 06798-0505
DEVICE: DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GL
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K021396(TRADITIONAL)
ATTN: V. NADARAJAN PHONE NO : 603 870 69788
LOT11 JALAN2 PERUSAHAAN BANDAR SE DECISION MADE: 16-MAY-02
KAWASAN BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG, SELANGOR, MALAYSIA 43900
DEVICE: HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
WUJIANG CITY HUA XIN MEDICAL APPLI510(k) NO: K021095(TRADITIONAL)
ATTN: LAURA J THORNE PHONE NO : 828-670-5464
10 WESTMONT ROAD SE DECISION MADE: 17-MAY-02
CANDLER, NC 28715 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 343
TOTAL WITH SUMMARIES 276
TOTAL WITH STATEMENTS 67
Updated June 19, 2002
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