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510(k)s Final Decisions Rendered for May 2001 |
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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-2001 THROUGH 31-MAY-2001
DEVICE: XSE
3M COMPANY 510(k) NO: K011167(TRADITIONAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 17-MAY-01
ST PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL BY <GENX> BLASTOCYST MEDIA
GENX INTL., INC. 510(k) NO: K010183(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453
170 FORT PATH RD., UNIT 14 SE DECISION MADE: 02-MAY-01
MADISON, CT 06443 510(k) STATEMENT
DEVICE: BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MO
A & A MEDICAL, INC. 510(k) NO: K010510(TRADITIONAL)
ATTN: JIHAD (JAY) MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 16-MAY-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ACCLAIM ENCORE, MODEL 12237
ABBOTT LABORATORIES 510(k) NO: K011096(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
200 ABBOTT PARK ROAD SE DECISION MADE: 01-MAY-01
ABBOTT PARK, IL 60064 510(k) STATEMENT
DEVICE: CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT R
ABBOTT LABORATORIES 510(k) NO: K011217(SPECIAL)
ATTN: THOMAS P SAMPOGNA PHONE NO : 847-935-3715
DEPT. 389, BLDG. AP30 SE DECISION MADE: 16-MAY-01
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6157
DEVICE: ACON STREP A RAPID TEST STRIP
ACON LABORATORIES CO. 510(k) NO: K010582(TRADITIONAL)
ATTN: ROBERT HUDAK PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 07-MAY-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVEECG
ACTIVE CORPORATION 510(k) NO: K010587(ABBREVIATED)
ATTN: KAREN SIEGEL PHONE NO : 207-326-9100
15 MAIN STREET SE DECISION MADE: 16-MAY-01
CASTINE, ME 04421-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
ADVANCED SURGICAL CONCEPTS (ASC) 510(k) NO: K010711(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 22-MAY-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD),
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K011224(TRADITIONAL)
ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 04-MAY-01
BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TISSUE MARKER
ADVANCED UROSCIENCE INC. 510(k) NO: K001807(TRADITIONAL)
ATTN: KAREN E PETERSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 03-MAY-01
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
AESCULAP, INC. 510(k) NO: K002824(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 08-MAY-01
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
DEVICE: AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND,
AFX INC. 510(k) NO: K003978(TRADITIONAL)
ATTN: NANCY NORRIS PHONE NO : 510-651-7430
47929 FREMONT BOULEVARD SE DECISION MADE: 22-MAY-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K003819(TRADITIONAL)
ATTN: TERESA SKARR PHONE NO : 206-664-5000
2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 02-MAY-01
SEATTLE, WA 98121 510(k) STATEMENT
DEVICE: AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3
AGILENT TECHNOLOGIES, INC. 510(k) NO: K011093(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 01-MAY-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K003647(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE T
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K003845(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE T
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K003847(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K003879(TRADITIONAL)
ATTN: NAIISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K003881(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW METHADONE URINE DIP STRIP TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010014(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW METHADONE URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010015(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010045(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010047(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010079(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010080(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K010125(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 619-350-9798
12330 STOWE DR. SE DECISION MADE: 29-MAY-01
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K011186(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 25-MAY-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 U
ALOKA CO., LTD. 510(k) NO: K011314(TRADITIONAL)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 15-MAY-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
ALOKA CO., LTD. 510(k) NO: K011315(TRADITIONAL)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 15-MAY-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALOKA SSD-5500 WITH KI AND A-SMA
ALOKA CO., LTD. 510(k) NO: K011457(TRADITIONAL)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 23-MAY-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMBU GEL, HYDROGEL BURN DRESSING
AMBU, INC. 510(k) NO: K010583(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 25-MAY-01
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: ALPCO MILENIA ANTI-TPO ELISA
AMERICAN LABORATORY PRODUCTS CO., 510(k) NO: K011201(TRADITIONAL)
ATTN: RICHARD E CONLEY PHONE NO : 603-893-8914
P.O. BOX 451 SE DECISION MADE: 24-MAY-01
WINDHAM, NH 03087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPCO MILENIA ANTI-TG EIA
AMERICAN LABORATORY PRODUCTS CO., 510(k) NO: K011415(TRADITIONAL)
ATTN: RICHARD E CONLEY PHONE NO : 603-893-8914
P.O. BOX 451 SE DECISION MADE: 30-MAY-01
WINDHAM, NH 03087 510(k) STATEMENT
DEVICE: ATLAST DATA MANAGEMENT SOFTWARE (DMS)
AMIRA MEDICAL, INC. 510(k) NO: K010605(TRADITIONAL)
ATTN: NINA PELED PHONE NO : 408-440-5448
4742 SCOTTS VALLEY DR. SE DECISION MADE: 07-MAY-01
SCOTTS VALLEY, CA 95066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMYSEAT TILT/RECLINE SEATING
AMYSYSTEMS 510(k) NO: K011006(TRADITIONAL)
ATTN: SYLVAIN DUGAS PHONE NO : 514-453-0311
178, WEST SERVICE ROAD SE DECISION MADE: 11-MAY-01
CHAMPLAIN, NY 12919 510(k) STATEMENT
DEVICE: OB-1 FETAL MONITOR
ANALOGIC CORP. 510(k) NO: K011304(SPECIAL)
ATTN: STEVEN A CLARKE PHONE NO : 978-977-3000
360 AUDUBON RD. SE DECISION MADE: 29-MAY-01
WAKEFIELD, MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
ANDERSEN PRODUCTS, INC. 510(k) NO: K011077(SPECIAL)
ATTN: WENDY HEDRICK PHONE NO : 336-376-3000
3202 CAROLINE DR., SE DECISION MADE: 09-MAY-01
HEALTH SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HAW RIVER, NC 27258-8710
DEVICE: X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WIT
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K010961(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, SE SE DECISION MADE: 31-MAY-01
MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
APEX BIOTECHNOLOGY CORP. 510(k) NO: K011233(SPECIAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH STREET SE DECISION MADE: 18-MAY-01
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPAROSCOPIC HAND PORT
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K003871(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 31-MAY-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO IMPLANTABLE CLIP
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K011236(SPECIAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8000
22872 AVENIDA EMPRESSA SE DECISION MADE: 14-MAY-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
ARROW INTL., INC. 510(k) NO: K002256(TRADITIONAL)
ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400
9 PLYMOUTH ST. SE DECISION MADE: 03-MAY-01
EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
ARTHREX, INC. 510(k) NO: K010457(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 14-MAY-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
ARTHREX, INC. 510(k) NO: K010525(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 23-MAY-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
ARTHREX, INC. 510(k) NO: K010673(TRADITIONAL)
ATTN: BRETTE MASINO PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 14-MAY-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERC-D SPINEWAND
ARTHROCARE CORP. 510(k) NO: K010811(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 30-MAY-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTA SST GRAFT (>_6MM)
ATRIUM MEDICAL CORP. 510(k) NO: K010516(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 18-MAY-01
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: ADVANTA SST GRAFT (<6MM)
ATRIUM MEDICAL CORP. 510(k) NO: K010517(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 18-MAY-01
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: VACUCATH I.V. CATHETER INTRODUCTER
AUTO/CATH VASCULAR ACCESS, INC. 510(k) NO: K003187(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-206-9911
21092 BAKE PARKWAY SE DECISION MADE: 21-MAY-01
SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, CA 92630
DEVICE: SCAPHIX, STAPLE, FIXATION, BONE
AVANTA ORTHOPAEDICS, INC. 510(k) NO: K003033(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580
9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 30-MAY-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMWELL, MODEL 2900
AWARENESS TECHNOLOGY, INC. 510(k) NO: K010877(ABBREVIATED)
ATTN: MARY FREEMAN PHONE NO : 561-283-6540
1995 S.W. MARTIN HWY. SE DECISION MADE: 23-MAY-01
P.O. BOX 1679 510(k) STATEMENT
PALM CITY, FL 34990
DEVICE: DRX 2000
AXIOM WORLDWIDE, INC. 510(k) NO: K010292(TRADITIONAL)
ATTN: JIM GIBSON PHONE NO : 813-969-2414
3830 GUNN HWY. SE DECISION MADE: 01-MAY-01
TAMPA, FL 33364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA
B BRAUN 510(k) NO: K010485(TRADITIONAL)
ATTN: PAUL O'CONNELL PHONE NO : 847-733-8900
2934 CENTRAL STREET, SUITE 1A SE DECISION MADE: 18-MAY-01
EVANSTON, IL 60201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLEAGUE VOLUMETRIC INFUSION PUMP
BAXTER HEALTHCARE CORP. 510(k) NO: K010566(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
RT. 120 & WILSON RD. SE DECISION MADE: 15-MAY-01
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC US
BAYLIS MEDICAL CO., INC. 510(k) NO: K002565(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO :
5160 EXPLORER DRIVE, UNIT 5 SE DECISION MADE: 03-MAY-01
MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT
DEVICE: SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) R
BECKMAN COULTER, INC. 510(k) NO: K010597(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 29-MAY-01
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECKMAN COULTER DNASE B CALIBRATOR
BECKMAN COULTER, INC. 510(k) NO: K010696(TRADITIONAL)
ATTN: RICHARD T ROSS PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 10-MAY-01
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K011213(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 16-MAY-01
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN C
BEIJING REAGENT LATEX PRODUCTS 510(k) NO: K010947(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 25-MAY-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: BIOFIND
BIO-SCAN, INC. 510(k) NO: K003480(TRADITIONAL)
ATTN: BUTCH SMITH PHONE NO : 505-867-9854
6 WALDEN ROAD SE DECISION MADE: 11-MAY-01
CORRALES, NM 87048 510(k) STATEMENT
DEVICE: THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K010458(TRADITIONAL)
ATTN: STEVEN BOGGAN PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 10-MAY-01
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS,
BIOLITEC, INC. 510(k) NO: K010689(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 18-MAY-01
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANTALUM BEADS - RADIOGRAPHIC MARKER
BIOMET, INC. 510(k) NO: K010348(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-372-1510
56 EAST BELL DRIVE SE DECISION MADE: 03-MAY-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT KNEE SYSTEM
BIOMET, INC. 510(k) NO: K011219(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 18-MAY-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
BIOMET, INC. 510(k) NO: K011237(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-372-1612
P.O. BOX 587 SE DECISION MADE: 23-MAY-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A
BIONX IMPLANTS, INC. 510(k) NO: K010554(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 25-MAY-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K011380(SPECIAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 14-MAY-01
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOBELL
BIOPSYBELL S.A.S. 510(k) NO: K011104(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 860-633-8807
131 HIGHWOOD DRIVE SE DECISION MADE: 31-MAY-01
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPHERE MEDICAL INFUSION CATHETER
BIOSPHERE MEDICAL 510(k) NO: K003105(TRADITIONAL)
ATTN: JOHN BONASERA PHONE NO : 781-681-7900
1050 HINGHAM STREET SE DECISION MADE: 22-MAY-01
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNE
BLACKSTONE MEDICAL, INC. 510(k) NO: K003735(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 08-MAY-01
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560
BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K003251(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 23-MAY-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
BONUTTI RESEARCH, INC. 510(k) NO: K010479(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
2600 SOUTH RANEY SE DECISION MADE: 08-MAY-01
P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401
DEVICE: VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
BRAINLAB AG 510(k) NO: K003589(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 21-MAY-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
BRAUN GMBH 510(k) NO: K003732(TRADITIONAL)
ATTN: FRED SCHLADOR PHONE NO : 760-929-2170
6183 PASEO DEL MORTE SE DECISION MADE: 16-MAY-01
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: VASO PRESS DVT FOOT GARMENT #VP 520
BRITT CORP., INC. 510(k) NO: K003828(TRADITIONAL)
ATTN: J J BRITTON PHONE NO : 732-817-1122
16 CREST DR. SE DECISION MADE: 18-MAY-01
COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXHALE RF PROBE
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K011267(TRADITIONAL)
ATTN: TIM R WILLIAMS PHONE NO : 650-428-1600
1400N SHORELINE BLVD. SE DECISION MADE: 08-MAY-01
BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043 THIRD PARTY REVIEW
DEVICE: REGAL MOTOTRIZED 3 WHEELED VEHICLE
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K011227(SPECIAL)
ATTN: RICHARD A KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DRIVE SE DECISION MADE: 11-MAY-01
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: CADHEALTH SYSTEM, MODEL CHP-001
CADUCEUS HEALTH CARE LTD. 510(k) NO: K002514(TRADITIONAL)
ATTN: BARRY MARTIN PHONE NO : 902 425 5054
1809 BARRINGTON ST. STE 708 SE DECISION MADE: 31-MAY-01
HALIFAX NS, CANADA B3J 3K8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
CAMBRIDGE HEART, INC. 510(k) NO: K011324(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 23-MAY-01
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDMX
CAMSIGHT CO., INC. 510(k) NO: K010915(TRADITIONAL)
ATTN: JAY CHOI PHONE NO : 323-720-3100
1530 BEACH STREET SE DECISION MADE: 21-MAY-01
MONTEBELLO, CA 90640 510(k) STATEMENT
DEVICE: CG-900P FETAL/MATERNAL MONITOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K010552(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PEKERIS STREET SE DECISION MADE: 11-MAY-01
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
CARDIONET 510(k) NO: K003707(TRADITIONAL)
ATTN: DONALD CANAL PHONE NO : 858-550-0961
6199 CORNERSTONE CT. SE DECISION MADE: 16-MAY-01
EAST # 106 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLU
CD LEYCOM BV 510(k) NO: K003020(TRADITIONAL)
ATTN: TIM LENIHAN PHONE NO : 31 79 3621602
ARGONSTRAAT 116 SE DECISION MADE: 11-MAY-01
ZOETERMEER, NETHERLANDS 2718 SP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURE CHECK OVULATION PREDICTOR
CHEMBIO DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K010244(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 02-MAY-01
BEVERLY,, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
CLINICAL INNOVATIONS, INC. 510(k) NO: K003458(TRADITIONAL)
ATTN: DEAN WALLACE PHONE NO : 801-268-8200
6477 SOUTH COTTONWOOD STREET SE DECISION MADE: 03-MAY-01
MURRAY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT SPACER
CLINICAL TECHNOLOGIES, INC. 510(k) NO: K010680(TRADITIONAL)
ATTN: BOB JOHNSON PHONE NO : 760-256-2569
705 E. VIRGINIA WAY SE DECISION MADE: 23-MAY-01
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
BARSTOW, CA 92311
DEVICE: CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
CONCENTRIC MEDICAL, INC. 510(k) NO: K003084(TRADITIONAL)
ATTN: LINDA BRADLEY PHONE NO : 650-938-2100
2585 LEGHORN STREET SE DECISION MADE: 16-MAY-01
MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
CONCENTRIC MEDICAL, INC. 510(k) NO: K003086(TRADITIONAL)
ATTN: LINDA BRADLY PHONE NO : 650-938-2100
2585 LEGHORN STREET SE DECISION MADE: 16-MAY-01
MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTRIC RETRIEVER, MODEL 90030
CONCENTRIC MEDICAL, INC. 510(k) NO: K003410(TRADITIONAL)
ATTN: SAM LAZZARA PHONE NO : 650-938-2100
2585 LEGHORN STREET SE DECISION MADE: 22-MAY-01
MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 900
CONCENTRIC MEDICAL, INC. 510(k) NO: K003880(ABBREVIATED)
ATTN: SAM LAZZARA PHONE NO : 650-938-2100
2585 LEGHORN STREET SE DECISION MADE: 16-MAY-01
MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE
CONTRACT LATEX DIPPERS SDN BHD 510(k) NO: K011012(TRADITIONAL)
ATTN: VINAYAGAN RAMALINGAM PHONE NO : 603 807 2714
LOT 5B, 7A & 8A SE DECISION MADE: 01-MAY-01
KAWASAN MIEL 510(k) STATEMENT
BATANG KALI, SELANGOR, MALAYSIA 44300
DEVICE: COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
COOK UROLOGICAL, INC. 510(k) NO: K011157(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 03-MAY-01
P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460
DEVICE: COOLTOUCH "VARIA" ND:YAG LASER SYSTEM; COOLTOUCH "VARIA-II" ND:Y
COOLTOUCH CORPORATION 510(k) NO: K010316(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BOULEVARD SE DECISION MADE: 01-MAY-01
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
DADE BEHRING, INC. 510(k) NO: K010494(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
P.O. BOX 6101 SE DECISION MADE: 01-MAY-01
MAILING STATION 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK,, DE 19714
DEVICE: E-POWER
DALTON MEDICAL CORP. 510(k) NO: K010395(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129
1103 VENTURE CT. SE DECISION MADE: 11-MAY-01
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
DANMAR PRODUCTS, INC. 510(k) NO: K003630(TRADITIONAL)
ATTN: KAREN A LINDNER PHONE NO : 734-761-1990
221 JACKSON INDUSTRIAL DR. SE DECISION MADE: 29-MAY-01
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHITE MTA MATERIAL
DENTSPLY INTERNATIONAL 510(k) NO: K011009(TRADITIONAL)
ATTN: P.JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 02-MAY-01
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL TITANIUM MESH SYSTEM
DEPUY ACROMED 510(k) NO: K003043(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 08-MAY-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH SPINE SYSTEM
DEPUY ACROMED 510(k) NO: K010576(TRADITIONAL)
ATTN: FRANK MAAS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 23-MAY-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
DEPUY ACROMED 510(k) NO: K011182(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 16-MAY-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISTULOK FISTULA NEEDLE PROTECTION
DIASOL INC. 510(k) NO: K010958(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 18-MAY-01
NORTH HOLLYWOOD, CA 91605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEEDLELOK HYPODERMIC NEEDLE PROTECTION
DIASOL INC. 510(k) NO: K011004(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 24-MAY-01
NORTH HOLLYWOOD, CA 91605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DJ ORTHOPEDICS POST SCREW
DJ ORTHOPEDICS, LLC 510(k) NO: K010594(TRADITIONAL)
ATTN: JAMAL D RUSHDY PHONE NO : 760-599-1674
990 PARK CENTER DRIVE, SUITE H SE DECISION MADE: 29-MAY-01
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DJ ORTHOPEDICS INTERFERENCE SCREW
DJ ORTHOPEDICS, LLC 510(k) NO: K010595(TRADITIONAL)
ATTN: JAMAL D RUSHDY PHONE NO : 760-599-1674
990 PARK CENTER DRIVE, SUITE H SE DECISION MADE: 08-MAY-01
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON STS
DYNATRONICS CORP. 510(k) NO: K010565(TRADITIONAL)
ATTN: JOHN S RAMEY PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 15-MAY-01
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON STS RX
DYNATRONICS CORP. 510(k) NO: K010948(TRADITIONAL)
ATTN: JOHN S RAMEY PHONE NO : 800-874-6251
7030 PARK CENTRE DR. SE DECISION MADE: 15-MAY-01
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z EM PERCUPUMP 2001 CT INJECTOR
E-Z-EM, INC. 510(k) NO: K011160(SPECIAL)
ATTN: BOB WILLIAMS PHONE NO : 516-333-8230
717 MAIN ST. SE DECISION MADE: 16-MAY-01
WESTBURY, NY 11590 510(k) STATEMENT
DEVICE: EBI DYNAFIX VS OSTEOTOMY SYSTEM
EBI, L.P. 510(k) NO: K010551(TRADITIONAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 17-MAY-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNETEC
ELA MEDICAL, LLC 510(k) NO: K002817(TRADITIONAL)
ATTN: SUSAN OLIVE PHONE NO : 763-519-9400
2950 XENIUM LN. NORTH, #120 SE DECISION MADE: 02-MAY-01
PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EDI VERIS SYSTEM
ELECTRO-DIAGNOSTIC IMAGING, INC. 510(k) NO: K003442(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 04-MAY-01
LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENSTAT
ELMED, INC. 510(k) NO: K010465(TRADITIONAL)
ATTN: WERNER HAUSNER PHONE NO : 630-543-2792
60 WEST FAY AVE. SE DECISION MADE: 14-MAY-01
ADDISON, IL 60101 510(k) STATEMENT
DEVICE: SANARUS CORE TISSUE BIOPSY SYSTEM
ENDOCARE, INC. 510(k) NO: K003528(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424
7 STUDEBAKER SE DECISION MADE: 03-MAY-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPO2 WRAP SENSOR
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K002848(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300 SE DECISION MADE: 24-MAY-01
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIPAR FREELIGHT
ESPE DENTAL AG 510(k) NO: K011154(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 16-MAY-01
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH
ETHICON ENDO-SURGERY, INC. 510(k) NO: K010898(TRADITIONAL)
ATTN: RUTH ANN WOOD PHONE NO : 513-337-8824
4545 CREEK RD. SE DECISION MADE: 31-MAY-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
EXACTECH, INC. 510(k) NO: K011218(SPECIAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-MAY-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
EXELINT INTERNATIONAL COMPANY 510(k) NO: K010197(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 W. CENTINELA AVENUE SE DECISION MADE: 14-MAY-01
LOS ANGELES, CA 90231-3194 510(k) STATEMENT
DEVICE: SMARTFLOW, MODEL SFIP 2000
FLORENCE MEDICAL LTD. 510(k) NO: K003122(TRADITIONAL)
ATTN: SHOSHANA FREIDMAN, RAC PHONE NO : 972 977 18130
117 AHUZAH STREET SE DECISION MADE: 14-MAY-01
RA'ANANNA 43373, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET, MODELS FP6T5, FP5T5, FP5T3
GALIL MEDICAL LTD. 510(k) NO: K010991(SPECIAL)
ATTN: JOHATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST. SE DECISION MADE: 03-MAY-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 9, MODEL 2188900-X
GE MEDICAL SYSTEM 510(k) NO: K011188(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
PO BOX 414 SE DECISION MADE: 18-MAY-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN-PROBE APTIMA COMBO 2 ASSAY
GEN-PROBE INC. 510(k) NO: K003395(TRADITIONAL)
ATTN: E. JOSEPH MCMULLEN PHONE NO : 858-410-8649
10210 GENETIC CENTER DR. SE DECISION MADE: 21-MAY-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: ALANTE, BATTERY OPERATED POWER WHEELCHAIR
GOLDEN TECHNOLOGIES, INC. 510(k) NO: K011153(TRADITIONAL)
ATTN: FRED KIWAK PHONE NO : 800-624-6374
401 BRIDGE ST. SE DECISION MADE: 29-MAY-01
OLD FORGE, PA 18518 510(k) STATEMENT
DEVICE: GOODNET
GOODMAN CO.,LTD. 510(k) NO: K010763(TRADITIONAL)
ATTN: DOUGLAS F ORR PHONE NO : 203-438-3535
109 DANBURY RD. SE DECISION MADE: 25-MAY-01
RIDGEFIELD, CT 06877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSIL FABRIC
GOTTFRIED MEDICAL, INC. 510(k) NO: K010675(TRADITIONAL)
ATTN: BRENT M GOTTFRIED PHONE NO : 419-474-2972
4105 W. ALEXIS RD. SE DECISION MADE: 30-MAY-01
TOLEDO, OH 43623-0966 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
GRAMS AMERICAN SUTURE, INC. 510(k) NO: K010672(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227
2225 DAKOTA DRIVE SE DECISION MADE: 18-MAY-01
GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDANT RETRIEVER DEVICE
GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K001694(TRADITIONAL)
ATTN: BERNICE JURS PHONE NO : 650-470-6200
1525 O'BRIEN DR. SE DECISION MADE: 15-MAY-01
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILINK .018 BILIARY STENT SYSTEM
GUIDANT CORP. 510(k) NO: K011039(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 408-845-1419
3200 LAKESIDE DR. SE DECISION MADE: 08-MAY-01
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: HARDKYDISK NEOMYCIN, 30 MCG
HARDY DIAGNOSTICS 510(k) NO: K011385(TRADITIONAL)
ATTN: MELISSA M TRAYLOR, RAC PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 18-MAY-01
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007
HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K011115(SPECIAL)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 02-MAY-01
AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANALYST PANELS + ANALYTICAL TEST ROTOR
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K010864(TRADITIONAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 21-MAY-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RAICHEM CREATININE URINE STANDARD
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K011126(SPECIAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 02-MAY-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: VERSYO.COM
HERAEUS KULZER, INC. 510(k) NO: K010800(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785
99 BUSINESS PARK DRIVE SE DECISION MADE: 31-MAY-01
ARMONK, NY 10504-1720 510(k) STATEMENT
DEVICE: RD-3008
HERAEUS KULZER, INC. 510(k) NO: K011036(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600
99 BUSINESS PARK DRIVE SE DECISION MADE: 10-MAY-01
ARMONK, NY 10504-1720 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL EXAM GLOVES
HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K011412(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 31-MAY-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
HIGHLAND / MARIETTA, INC. 510(k) NO: K003403(TRADITIONAL)
ATTN: JOHN NIKSA PHONE NO : 440-354-0957
6155 HEISLEY ROAD SE DECISION MADE: 07-MAY-01
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOP
HIGHLAND / MARIETTA, INC. 510(k) NO: K003405(TRADITIONAL)
ATTN: JOHN NIKSA PHONE NO : 440-354-0957
6155 HEISLEY ROAD SE DECISION MADE: 07-MAY-01
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
HITACHI MEDICAL CORP. 510(k) NO: K011252(TRADITIONAL)
ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711
660 WHITE PLAINS ROAD SE DECISION MADE: 30-MAY-01
TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
HORIZONS INTL. CORP. 510(k) NO: K010448(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
287 MONTERREY STREET SE DECISION MADE: 16-MAY-01
PONCE, PR 00732 510(k) STATEMENT
DEVICE: APEX FIXATION PINS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011136(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 04-MAY-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR ASSIST
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K002186(TRADITIONAL)
ATTN: AUDREY A WITKO PHONE NO : 800-223-1218
40 CHRISTOPHER WAY SE DECISION MADE: 02-MAY-01
EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
HWA TEH INDUSTRIAL SDN. BHD. 510(k) NO: K010803(TRADITIONAL)
ATTN: ABDUL HALIM ARSHAD PHONE NO : 603 327 17351
LOT 187, SUNGAI DAHAR SE DECISION MADE: 11-MAY-01
45600 BATANG BERJUNTAI 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 45600
DEVICE: VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DET
ID BIOMEDICAL CORP. 510(k) NO: K010858(TRADITIONAL)
ATTN: DAVID CLARY PHONE NO : 425-482-2601
19204 N. CREEK PKWAY., STE 100 SE DECISION MADE: 24-MAY-01
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNETICS C6 LYME ELISA KIT
IMMUNETICS, INC. 510(k) NO: K003754(TRADITIONAL)
ATTN: ANDREW E LEVIN PHONE NO : 617-492-5416
63 ROGERS ST. SE DECISION MADE: 10-MAY-01
CAMBRIDGE,, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
IMPRA, INC. 510(k) NO: K004012(TRADITIONAL)
ATTN: LORRI CHAVEZ PHONE NO : 602-894-9515
1625 WEST 3RD ST. SE DECISION MADE: 14-MAY-01
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281
DEVICE: BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
INJECTX INC. 510(k) NO: K010533(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4040
2195 TRADE ZONE BLVD. SE DECISION MADE: 24-MAY-01
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K000733(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 21-MAY-01
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMET
INSTRUMENTATION LABORATORY CO. 510(k) NO: K010520(TRADITIONAL)
ATTN: REBA POIRIER PHONE NO : 781-861-4285
113 HARTWELL AVE. SE DECISION MADE: 07-MAY-01
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL
INTERNATIONAL ENZYMES, INC 510(k) NO: K011169(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432-B SOUTH MISSION ROAD SE DECISION MADE: 18-MAY-01
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
INTUITIVE SURGICAL, INC. 510(k) NO: K011002(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 650-237-7013
1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 30-MAY-01
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KILEJIAN CIRCUMCISOR
IRIS SURGICAL 510(k) NO: K010867(TRADITIONAL)
ATTN: V. JOHN KILEJIAN PHONE NO : 904-827-1870
446 ARRICOLA AVENUE SE DECISION MADE: 03-MAY-01
ST.AUGUSTINE, FL 32080-4566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOUNIVERSAL PDF
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K011022(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 02-MAY-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: D.SIGN 96
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K011023(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 02-MAY-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: GOLD CORE 73 LS
JENERIC/PENTRON, INC. 510(k) NO: K011362(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 29-MAY-01
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
KAMIYA BIOMEDICAL CO. 510(k) NO: K002948(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8086
910 INDUSTRY DR. SE DECISION MADE: 18-MAY-01
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY HS-CRP CONTROLS
KAMIYA BIOMEDICAL CO. 510(k) NO: K011079(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 16-MAY-01
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K010346(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 02-MAY-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KM-30 TENS ELECTRODE
KATECHO, INC. 510(k) NO: K010543(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 23-MAY-01
P.O. BOX 21247 510(k) STATEMENT
DES MOINES, IA 50321
DEVICE: GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
KINAMED, INC. 510(k) NO: K010101(TRADITIONAL)
ATTN: JOEL SLOMOFF PHONE NO : 301-983-1707
820 FLYNN ROAD SE DECISION MADE: 17-MAY-01
CAMARILLO,, CA 93012 510(k) STATEMENT
DEVICE: LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF
LAGLOVE (M) SDN. BHD. 510(k) NO: K010863(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 873 35411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 03-MAY-01
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: MANDREL GUIDEWIRE ASSEMBLY
LAKE REGION MFG., INC. 510(k) NO: K011084(SPECIAL)
ATTN: JIM KLOSTERMAN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 10-MAY-01
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG
LASERSCOPE 510(k) NO: K010284(TRADITIONAL)
ATTN: PAUL H HARDIMAN PHONE NO : 408-943-0636
3070 ORCHARD DR. SE DECISION MADE: 01-MAY-01
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE 510(k) NO: K010834(TRADITIONAL)
ATTN: PAUL H HARDIMAN PHONE NO : 800-243-9384
3052 ORCHARD DRIVE SE DECISION MADE: 21-MAY-01
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
LIFECORE BIOMEDICAL, INC. 510(k) NO: K002037(TRADITIONAL)
ATTN: CAROLYN ANDERSON PHONE NO : 952-368-6324
3515 LYMAN BLVD. SE DECISION MADE: 16-MAY-01
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADCALC, MODEL V.4.0
LIFELINE SOFTWARE, INC. 510(k) NO: K010464(TRADITIONAL)
ATTN: CRAIG A LAUGHTON PHONE NO : 903-592-1343
403 MOCKINGBIRD LN. SE DECISION MADE: 17-MAY-01
TYLER, TX 75701-3053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFELINES TRACKIT
LIFELINES LTD. 510(k) NO: K010460(TRADITIONAL)
ATTN: CRHISTINA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 14-MAY-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: RUBICON PROTHROMBIN TIME MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K001699(TRADITIONAL)
ATTN: JOHN E HUGHES PHONE NO : 408-263-9789
1000 GIBRALTAR DR. SE DECISION MADE: 15-MAY-01
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROGAS 7650 TRANSCUTANEOUS MONITOR
LINDE MEDICAL SENSORS AG 510(k) NO: K003943(SPECIAL)
ATTN: JEAN-PIERRE PALMA PHONE NO : 011 416 12788207
AUSTRASSE 25 SE DECISION MADE: 04-MAY-01
BASEL, SWITZERLAND 4051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORENS CRANILOC
MACROPORE, INC. 510(k) NO: K002334(TRADITIONAL)
ATTN: KENNITH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 02-MAY-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC VIEW, MODEL 2001
MAGNA-LAB, INC. 510(k) NO: K010513(TRADITIONAL)
ATTN: LYNN CARTER PHONE NO : 617-964-9100
150 CALIFORNIA STREET SE DECISION MADE: 21-MAY-01
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
MARCONI MEDICAL SYSTEMS 510(k) NO: K010691(TRADITIONAL)
ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 08-MAY-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOALA CLAMP
MATERNUS, INC. 510(k) NO: K010695(TRADITIONAL)
ATTN: RONALD B HICKS PHONE NO : 210-479-4001
13223 HUNTERS LARK SE DECISION MADE: 03-MAY-01
SAN ANTONIO, TX 78230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
MAXXIM MEDICAL 510(k) NO: K002847(ABBREVIATED)
ATTN: GAIL DOHERTY PHONE NO : 903-675-9321
1445 FLAT CREEK ROAD SE DECISION MADE: 31-MAY-01
ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION G
MAXXIM MEDICAL, INC. 510(k) NO: K011198(TRADITIONAL)
ATTN: JAMAL S ALNASER PHONE NO : 727-561-2108
10300 49TH STREET NORTH SE DECISION MADE: 17-MAY-01
CLEARWATER, FL 33762 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DCM 1.0
MDS NORDION, INC. 510(k) NO: K011246(SPECIAL)
ATTN: E.S. MARTELL PHONE NO : 613 592 3400
447 MARCH RD. SE DECISION MADE: 23-MAY-01
KANATA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMREST
MEDICAL INDUSTRIES AMERICA, INC. 510(k) NO: K002763(TRADITIONAL)
ATTN: ANNE B CARLSON PHONE NO : 515-993-5001
2636 289TH PLACE SE DECISION MADE: 04-MAY-01
ADEL, IA 50003-8021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAT - NUCLEIC ACID TRANSPORT
MEDICAL PACKAGING CORP. 510(k) NO: K003761(TRADITIONAL)
ATTN: RICHARD CURTIS PHONE NO : 805-388-2383
941 AVENIDA ACASO SE DECISION MADE: 31-MAY-01
CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS M ELECTRODE
MEDICAL PHYSICS AND SERVICES INC. 510(k) NO: K002801(TRADITIONAL)
ATTN: HOWARD C THOMAS PHONE NO : 303-452-9997
1091 IRMA DRIVE, UNIT C SE DECISION MADE: 04-MAY-01
DENVER, CO 80233 510(k) STATEMENT
DEVICE: MEDISYSTEMS LUER ACCESS INJECTION SITE
MEDISYSTEMS CORP. 510(k) NO: K010279(TRADITIONAL)
ATTN: KAREN KRSTULICH PHONE NO : 206-834-1200
701 PIKE STREET, SUITE 1600 SE DECISION MADE: 29-MAY-01
SEATTLE, WA 98101-3016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE STERISET STERILIZATION CONTAINER
MEDLINE 510(k) NO: K010825(TRADITIONAL)
ATTN: STACEY L BOLEN PHONE NO : 847-837-2843
ONE MEDLINE PLACE SE DECISION MADE: 08-MAY-01
MUNDLELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100
MEDTRONIC PS MEDICAL 510(k) NO: K010361(TRADITIONAL)
ATTN: CAROL BACCASH PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 07-MAY-01
UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: BIPOLAR PENCIL, MODEL 3901-002, 3900-002
MEDTRONIC PS MEDICAL 510(k) NO: K010487(ABBREVIATED)
ATTN: JANET MCAULEY PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 03-MAY-01
UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K011067(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 04-MAY-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTTERFLY PLATE FUNCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K010632(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 31-MAY-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
MEDTRONIC XOMED, INC 510(k) NO: K010666(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 07-MAY-01
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPS 3000 SYSTEM
MEDTRONIC XOMED, INC 510(k) NO: K010677(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 07-MAY-01
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTAB
MEDTRONIC, INC. 510(k) NO: K011098(SPECIAL)
ATTN: STACEY P WESSMAN PHONE NO : 763-514-9840
7000 CENTRAL AVENUE N.E. SE DECISION MADE: 04-MAY-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOTRAC APM205A
MEDWAVE, INC. 510(k) NO: K011152(TRADITIONAL)
ATTN: DONNA R LUNAK PHONE NO : 651-639-1227
4382 ROUND LAKE RD. WEST SE DECISION MADE: 31-MAY-01
ARDEN HILLS, MN 55112-3923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K001120(TRADITIONAL)
ATTN: KEN RAICHMAN PHONE NO : 728-938-3030
KIRYAT WEIZMANN SCIENCE PARK SE DECISION MADE: 08-MAY-01
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: BRIDGE III RECEIVER
MERIDIAN MEDICAL TECHNOLOGIES LTD.510(k) NO: K010794(TRADITIONAL)
ATTN: RHONA LOVE PHONE NO : 442 890 222333
207 AIRPORT RD., WEST SE DECISION MADE: 10-MAY-01
BELFAST, IRELAND BT3 9ED 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MP3HD BIG BOY, POWER WHEELCHAIR
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K010380(ABBREVIATED)
ATTN: WINSTON ANDERSON PHONE NO : 941-772-0579
P.O. BOX 150356 SE DECISION MADE: 09-MAY-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: VECTORSURGE 5, MODEL VS-500
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K002058(TRADITIONAL)
ATTN: ROB HOPKINS PHONE NO : 61 397 751234
57 ASTER AVE. SE DECISION MADE: 29-MAY-01
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104
MICRO THERAPEUTICS, INC. 510(k) NO: K010162(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 18-MAY-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
MICROGENICS CORP. 510(k) NO: K010496(TRADITIONAL)
ATTN: SHERRIE RINNE PHONE NO : 510-979-5150
46360 FREMONT BLVD. SE DECISION MADE: 29-MAY-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEISS RETINAL CANNULA
MICRON SURGICAL, INC. 510(k) NO: K010305(TRADITIONAL)
ATTN: APRIL DEAN PHONE NO : 415-464-0123
5800 COLONIAL DR SE DECISION MADE: 02-MAY-01
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MARGATE, FL 33063
DEVICE: ACTIWARE-PLMS
MINI-MITTER CO., INC. 510(k) NO: K011430(SPECIAL)
ATTN: JACK E MCKENZIE PHONE NO : 541-322-7272
20300 EMPIRE AVE. BLDG. B-3 SE DECISION MADE: 31-MAY-01
BEND, OR 97701 510(k) STATEMENT
DEVICE: BIOKNOTLESS ANCHOR
MITEK PRODUCTS 510(k) NO: K002639(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781-251-3134
249 VANDERBILT AVE. SE DECISION MADE: 11-MAY-01
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
MITEK PRODUCTS 510(k) NO: K010633(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781-251-3134
249 VANDERBILT AVE SE DECISION MADE: 09-MAY-01
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
MODULAR X-RAY DEVICES 510(k) NO: K011111(TRADITIONAL)
ATTN: S.B.B. DESEMBERG PHONE NO : 27 011 7945523
P.O. BOX 2878 SE DECISION MADE: 30-MAY-01
HONEYDEW 2040 510(k) SUMMARY AVAILABLE FROM FDA
ROODEPOORT, SOUTH AFRICA 2040
DEVICE: MODIFICATION TO MALE TO MALE LUER ADAPTER
MOLDED PRODUCTS 510(k) NO: K003712(TRADITIONAL)
ATTN: ELISE JOHNSTON PHONE NO : 712-755-5557
P.O. BOX 15 SE DECISION MADE: 16-MAY-01
HARLAN, IA 51537 510(k) STATEMENT
DEVICE: KFA-127 KNEE, FOOT AND ANKLE ARRAY
MRI DEVICES CORP. 510(k) NO: K003505(TRADITIONAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DRIVE SE DECISION MADE: 25-MAY-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTE
N.S. UNI-GLOVES SDN. BHD. 510(k) NO: K010879(TRADITIONAL)
ATTN: ROBERT D VANDER LEEK PHONE NO : 310-328-7981
2420 CARSON STREET SE DECISION MADE: 10-MAY-01
SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA
TORRENCE, CA 90501
DEVICE: UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WIT
N.S. UNI-GLOVES SDN. BHD. 510(k) NO: K010881(TRADITIONAL)
ATTN: ROBERT D VANDER PHONE NO : 310-328-7981
UG HEALTHCARE (USA) INC SE DECISION MADE: 16-MAY-01
2420 CARSON ST. SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA
TORRANCE, CA 90501
DEVICE: SIMPLICT
NEORAD AS 510(k) NO: K010813(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLAN LANE SE DECISION MADE: 07-MAY-01
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROFAX, MODELS EEG-1100A, EEG-9100A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K011204(SPECIAL)
ATTN: BONNIE BISHOP PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 08-MAY-01
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE EXAM GLOVE, BLUE
NINGBO YUJIANG PLASTIC & RUBBER CO510(k) NO: K011286(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D' EMERALD SE DECISION MADE: 16-MAY-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
NIPRO DIABETES SYSTEMS, INC. 510(k) NO: K011120(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 08-MAY-01
LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA-OS SIZING BALLOON, MODEL 360
NUMED, INC. 510(k) NO: K003320(TRADITIONAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 02-MAY-01
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE OFFICAL CONDOM OF THE 21ST CENTURY (TM)
OCEANS SEVEN. INTN'L. 510(k) NO: K010506(ABBREVIATED)
ATTN: FRANK C SADLO PHONE NO : 502-634-3221
P.O. BOX 32222 SE DECISION MADE: 22-MAY-01
LOUISVILLE, KY 40232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMODIALYSIS TUBING SETS
OFI BIOMEDICA S.P.A. 510(k) NO: K001971(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 24-MAY-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
ONUX MEDICAL, INC. 510(k) NO: K010620(TRADITIONAL)
ATTN: JOHN RICE PHONE NO : 603-929-6200
5 MERRILL DR. SE DECISION MADE: 17-MAY-01
HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (
OPTECH, INC. 510(k) NO: K004049(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 23-MAY-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTAFLEX SURGICAL SLING
ORGANOGENESIS INC. 510(k) NO: K011027(TRADITIONAL)
ATTN: PATRICK R BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 30-MAY-01
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTREAM ORAL NASAL CANNULA FILTERLINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K011050(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 04-MAY-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
ORTHODYNE INC. 510(k) NO: K010322(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-316-8098
1118 SO. ORANGE AVENUE SE DECISION MADE: 02-MAY-01
SUITE 204 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32806
DEVICE: SCS CLOSED SCREW
ORTHOTEC, L.L.C. 510(k) NO: K003733(TRADITIONAL)
ATTN: PATRICK BERTRANOU PHONE NO : 310-557-2000
546 HILLGREEN DR. SE DECISION MADE: 29-MAY-01
BEVERLY HILLS, CA 90212-4110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARIS PLATE SYSTEM
ORTHOTEC, L.L.C. 510(k) NO: K010369(TRADITIONAL)
ATTN: PATRICK BERTRANOU PHONE NO : 310-557-2000
546 HILLGREEN DR. SE DECISION MADE: 08-MAY-01
BEVERLY HILLS, CA 90212-4110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
OSCOR, INC. 510(k) NO: K003918(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DESOTO BLVD. SE DECISION MADE: 22-MAY-01
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
OSCOR, INC. 510(k) NO: K010787(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DESOTO BLVD. SE DECISION MADE: 22-MAY-01
PALM HARBOR, FL 34683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.0/2.4 CANNULATED SCREW SYSTEM
OSTEOMED CORP. 510(k) NO: K010783(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 30-MAY-01
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
OSTEOMETER BIOTECH A/S 510(k) NO: K003609(TRADITIONAL)
ATTN: PER QVIST PHONE NO : 454 454 7777
HERLEV HOVEDGADE 207 SE DECISION MADE: 16-MAY-01
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR SLP 1000
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K010580(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 22-MAY-01
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K003318(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-977-8970
2355 SOUTH 1070 WEST SE DECISION MADE: 22-MAY-01
SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D/C CORE MATERIAL
PARKELL, INC. 510(k) NO: K010475(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 07-MAY-01
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K011271(TRADITIONAL)
ATTN: TAN KONG CHAN PHONE NO : 603 329 11949
LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 08-MAY-01
SELANGOR, MALAYSIA 41720 510(k) STATEMENT
DEVICE: RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
PLUS ORTHOPEDICS 510(k) NO: K003504(TRADITIONAL)
ATTN: HARMTMUT LOCH PHONE NO : 858-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 11-MAY-01
BLDG. #15-100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-1194
DEVICE: TC-PLUS POROUS FEMORAL COMPONENTS
PLUS ORTHOPEDICS 510(k) NO: K011258(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 24-MAY-01
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TC-PLUS POROUS TIBIAL COMPONENTS
PLUS ORTHOPEDICS 510(k) NO: K011288(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 24-MAY-01
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN,
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K010483(SPECIAL)
ATTN: ANIL TANEJA PHONE NO : 62 061 4515834
JL. LET-JEN. S. PARMAN SE DECISION MADE: 03-MAY-01
NO. 23/235 510(k) STATEMENT
MEDAN, INDONESIA 20153
DEVICE: PELVEX HOMETRAINER
PURDUE TECHNOLOGY PARK 510(k) NO: K002043(TRADITIONAL)
ATTN: CHRISTOPH WEISMAYER PHONE NO : 765-494-5922
3000 KENT AVENUE SE DECISION MADE: 21-MAY-01
SUITE D1-113 510(k) SUMMARY AVAILABLE FROM FDA
WEST LAFAYETTE, IN 47906
DEVICE: SPHYGMOCOR MX MODEL SCOR-MX
PWV MEDICAL PTY, LT. 510(k) NO: K002742(TRADITIONAL)
ATTN: KIRSTEN H PAULSON PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 01-MAY-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
QRC CONSULTING 510(k) NO: K011105(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 30-MAY-01
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKVUE DIPSTICK STREP A
QUIDEL CORP. 510(k) NO: K011097(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 858-552-7908
10165 MCKELLAR CT. SE DECISION MADE: 08-MAY-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R & D 4K RETIC
R & D SYSTEMS, INC. 510(k) NO: K010470(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 11-MAY-01
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS COUGAR WIRE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K011287(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 25-MAY-01
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX MYOGLOBIN
RANDOX LABORATORIES, LTD. 510(k) NO: K010700(TRADITIONAL)
ATTN: P. ARMSTROMG PHONE NO : 028 944 22413
55 DIAMOND RD. SE DECISION MADE: 08-MAY-01
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: RANDOX IGE
RANDOX LABORATORIES, LTD. 510(k) NO: K010855(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 15-MAY-01
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: MODIFICATION TO SOLO
RANGER ALL SEASON CORP. 510(k) NO: K011107(SPECIAL)
ATTN: RON STEWART PHONE NO : 712-475-2811
2002 KINGBIRD AVE. SE DECISION MADE: 14-MAY-01
P.O. BOX 132 510(k) STATEMENT
GEORGE, IA 51237
DEVICE: REBSTOCK YASARGIL ANEURYSM CLIP
REBSTOCK - INSTRUMENTE GMBH 510(k) NO: K003500(TRADITIONAL)
ATTN: DIETER REBSTOCK PHONE NO : 497 424 6734
IN BREITEN 12 SE DECISION MADE: 30-MAY-01
DUERBHEIM, GERMANY 78589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING ST
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K010436(TRADITIONAL)
ATTN: CHRIS HANNAN PHONE NO : 44 125 6362400
THE AVENUE, FARLEIGH WALLOP SE DECISION MADE: 14-MAY-01
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 TH
RF INDUSTRIES, LTD. 510(k) NO: K010809(TRADITIONAL)
ATTN: DICK ROBERTS PHONE NO : 909-245-3656
541-A BIRCH ST. SE DECISION MADE: 23-MAY-01
LAKE ELSINORE, CA 92530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOU
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K011065(SPECIAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 09-MAY-01
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVA
RICHTER RUBBER TECHNOLOGY SDN. BHD510(k) NO: K011480(ABBREVIATED)
ATTN: FRANK C SADLO PHONE NO : 502-634-3221
BOX 32222 SE DECISION MADE: 24-MAY-01
LOUISVILLE, KY 40232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT ALPHA-1 ANTITRYPSIN
ROCHDIAG 510(k) NO: K010978(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE ROAD SE DECISION MADE: 18-MAY-01
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CAT
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003064(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 01-MAY-01
P.O. BOX 50457 510(k) STATEMENT
INDIANAPOLIS, IN 46250-0457
DEVICE: CRP HS TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003400(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 10-MAY-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: TINA-QUANT D-DIMER TEST SYSTEM
ROCHE DIAGNOSTICS CORPORATION 510(k) NO: K011143(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 29-MAY-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTO-PREP PARTICLE MICROBLASTER
RONVIG A/S 510(k) NO: K010816(TRADITIONAL)
ATTN: ANNETTE RAVN NIELSEN PHONE NO : 45 75 895711
GL VEJLEVELJ 57-59 SE DECISION MADE: 10-MAY-01
DK-8721 DAUGAARD, DENMARK DK-8721 510(k) STATEMENT
DEVICE: RUSCH MMG/O'NEIL CATHETER
RUSCH, INC. 510(k) NO: K010420(TRADITIONAL)
ATTN: WILLIAM SLEVIN PHONE NO : 770-623-0816
2450 MEADOWBROOK PKWY. SE DECISION MADE: 09-MAY-01
DULUTH, GA 30096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIC CEM
S & C POLYMER GMBH 510(k) NO: K011064(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 17-MAY-01
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESS
SAFETY SYRINGES, INC. 510(k) NO: K011369(TRADITIONAL)
ATTN: THOMAS L HALL PHONE NO : 760-918-9908
1925 PALOMAR OAKS WAY, #204 SE DECISION MADE: 29-MAY-01
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNUM FLOW IRRIGATION SYSTEM
SCION VALLEY, INC. 510(k) NO: K010519(TRADITIONAL)
ATTN: C. KENNETH FRENCH PHONE NO : 254-435-2306
HWY. 6 NORTH SE DECISION MADE: 14-MAY-01
MERIDIAN, TX 76665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEA-LONG MEDICAL TREATMENT HOOD
SEA-LONG MEDICAL SYSTEMS, INC. 510(k) NO: K010659(SPECIAL)
ATTN: GERALD COX PHONE NO : 502-969-4949
1983 SOUTH PARK ROAD SE DECISION MADE: 16-MAY-01
LOUISVILLE, KY 40219 510(k) STATEMENT
DEVICE: SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABL
SEEDLING ENTERPRISES. LLC 510(k) NO: K010710(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRIAL SE DECISION MADE: 18-MAY-01
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K011474(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 31-MAY-01
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K010773(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 30-MAY-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI ADVISOR VITAL SIGNS MONITOR (9200)
SIMS BCI, INC. 510(k) NO: K011177(TRADITIONAL)
ATTN: DONALD J ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 23-MAY-01
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
SKIL-CARE CORP. 510(k) NO: K010644(TRADITIONAL)
ATTN: ARNOLD SILVERMAN PHONE NO : 914-963-2040
29 WELLS AVE. SE DECISION MADE: 18-MAY-01
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT LIMB HOLDER, MODELS 306080 & 306081
SKIL-CARE CORP. 510(k) NO: K010818(TRADITIONAL)
ATTN: ARNOLD SILVERMAN PHONE NO : 914-963-2040
29 WELLS AVENUE SE DECISION MADE: 24-MAY-01
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAX GRANULES BONE VOID FILLER
SMITH & NEPHEW, INC. 510(k) NO: K010557(TRADITIONAL)
ATTN: TRUDE C MCLEAN PHONE NO : 800-821-5700
1450 E. BROOKS ROAD SE DECISION MADE: 25-MAY-01
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FO
SPECIALTY ULTRAVISION, INC. 510(k) NO: K011089(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 408-341-0700
307 ORCHARD CITY DR. SE DECISION MADE: 23-MAY-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008
DEVICE: END-TO-END AND SIDE-BY-SIDE CONNECTORS
SPINAL CONCEPTS, INC. 510(k) NO: K010563(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 25-MAY-01
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERGENCE CERVICAL SPINAL SYSTEM
SPINAL INNOVATIONS, LLC 510(k) NO: K010639(TRADITIONAL)
ATTN: KENNETH RUSSELL PHONE NO : 901-373-8855
7850 STAGE HILLS BLVD. SE DECISION MADE: 30-MAY-01
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BARTLETT, TN 38133
DEVICE: SYMMETRY AORTIC CLIP SYSTEM
ST. JUDE MEDICAL CARDIOVASCULAR GR510(k) NO: K003446(TRADITIONAL)
ATTN: ROBERT L SHERIDAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 21-MAY-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: HARMONE-SCHWARZER EEG SYSTEM
STELLATE SYSTEMS 510(k) NO: K010728(ABBREVIATED)
ATTN: GEORGE PAPAGIANNIS PHONE NO : 514 486 1306
345 VICTORIA AVE., SUITE 300 SE DECISION MADE: 21-MAY-01
WESTMOUNT, QUEBEC, CANADA H3Z 2N2 510(k) STATEMENT
DEVICE: AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
STERIS CORPORATION 510(k) NO: K010865(ABBREVIATED)
ATTN: RAYMOND URSICK PHONE NO : 440-392-7016
5960 HEISLEY ROAD SE DECISION MADE: 31-MAY-01
MENTOR, OH 44060-1834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIII ALARM AMPLIFIER
STOCKERT INSTRUMENTE GMBH 510(k) NO: K011088(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 02-MAY-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K010291(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 10-MAY-01
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: STEREOTACTIC FRAME BASED SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K003486(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 17-MAY-01
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMMER IV MICRODEBRIDER SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K011381(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 877-534-2464
4100 EAST MILHAM AVE. SE DECISION MADE: 25-MAY-01
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCREW-VENT DENTAL IMPLANT SYSTEM
SULZER DENTAL, INC. 510(k) NO: K011028(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 21-MAY-01
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPER-LOCK DENTAL IMPLANT SYSTEM
SULZER DENTAL, INC. 510(k) NO: K011038(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 15-MAY-01
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K010177(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 17-MAY-01
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: IVD (IN VIVO DOSIMETER), MODEL 1131
SUN NUCLEAR CORP. 510(k) NO: K010449(TRADITIONAL)
ATTN: NOEL M DOWNEY PHONE NO : 321-259-6862
425-A PINEDA COURT SE DECISION MADE: 04-MAY-01
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENAX A.V. FISTULA NEEDLE SETS
SUNDER BIOMEDICAL TECH. CO., LTD. 510(k) NO: K003123(TRADITIONAL)
ATTN: TONY HUNG PHONE NO : 886 4 3755650
10F-1, 1-67, WU-CHUAN RD. SE DECISION MADE: 04-MAY-01
TAICHUNG CITY, CHINA (TAIWAN) 403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS HUMIDIFIER
SUNRISE MEDICAL HHG, INC. 510(k) NO: K003626(TRADITIONAL)
ATTN: ALLAN R JONES PHONE NO : 814-443-7618
100 DEVILBISS DR. SE DECISION MADE: 04-MAY-01
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER TILT AND RECLINE SYSTEM
SUNRISE MEDICAL, INC. 510(k) NO: K010917(TRADITIONAL)
ATTN: JOHN GERHOLD PHONE NO : 303-218-4500
7477 EAST DRY CREEK PKWY. SE DECISION MADE: 15-MAY-01
LONGMONT, CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREEZY WHEELCHAIR, MODEL 300
SUNRISE MEDICAL, INC. 510(k) NO: K011268(TRADITIONAL)
ATTN: JOHN GERHOLD PHONE NO : 303-218-4500
7477 EAST DRY CREEK PKWY. SE DECISION MADE: 15-MAY-01
LONGMONT, CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESU HANDSWITCHING PENCIL
SURGEX, INC. 510(k) NO: K001442(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET NW. SE DECISION MADE: 31-MAY-01
7TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036-3307
DEVICE: SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K010542(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT ROAD SE DECISION MADE: 08-MAY-01
MISSISSAUGA ONTARIO, CANADA L4V 1S510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES SYNEX SPACER SYSTEM
SYNTHES 510(k) NO: K003836(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 29-MAY-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES RESORABLE MESHES AND SHEETS
SYNTHES (USA) 510(k) NO: K003788(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 30-MAY-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: MODULAR FOOT SYSTEM - 2.7 MM MODULE
SYNTHES (USA) 510(k) NO: K010321(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 02-MAY-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADJUSTABLE LARGE FIXATOR SYSTEM
SYNTHES (USA) 510(k) NO: K010344(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 03-MAY-01
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES (USA) MIDFACE DISTRACTOR
SYNTHES (USA) 510(k) NO: K010499(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-MAY-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES ANTEROLATERAL CALCANEAL PLATE
SYNTHES (USA) 510(k) NO: K010518(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 23-MAY-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
SYNTHES (USA) 510(k) NO: K010690(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 18-MAY-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
SYVA CO. 510(k) NO: K011347(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3403 YERBA BUENA ROAD SE DECISION MADE: 17-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9
SYVA CO., DADE BEHRING INC. 510(k) NO: K011161(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3403 YERBA BUENA ROAD SE DECISION MADE: 15-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
SYVA CO., DADE BEHRING INC. 510(k) NO: K011162(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3403 YERBA BUENA ROAD SE DECISION MADE: 02-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G
SYVA CO., DADE BEHRING INC. 510(k) NO: K011163(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3403 YERBA BUENA ROAD SE DECISION MADE: 10-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q
SYVA CO., DADE BEHRING INC. 510(k) NO: K011164(SPECIAL)
ATTN: CYNTHIA ARREDONDO PHONE NO : 408-239-2671
3403 YERBA BUENA ROAD SE DECISION MADE: 10-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
SYVA CO., DADE BEHRING INC. 510(k) NO: K011166(SPECIAL)
ATTN: VIRGINIA SINGER PHONE NO : 408-239-2175
3403 YERBA BUENA ROAD SE DECISION MADE: 10-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
SYVA CO., DADE BEHRING INC. 510(k) NO: K011289(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
P.O. BOX 49013 SE DECISION MADE: 15-MAY-01
3403 YERBA BUENA ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135
DEVICE: EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
SYVA CO., DADE BEHRING INC. 510(k) NO: K011300(SPECIAL)
ATTN: VIRGINIA SINGER PHONE NO : 408-239-2175
3403 YERBA BUENA ROAD SE DECISION MADE: 17-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
SYVA CO., DADE BEHRING INC. 510(k) NO: K011306(SPECIAL)
ATTN: CYNTHIA ARREDONO PHONE NO : 408-239-2671
3403 YERBA BUENA ROAD SE DECISION MADE: 16-MAY-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN
TERANG NUSA SDN BHD 510(k) NO: K010438(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 01-MAY-01
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEI
TERANG NUSA SDN BHD 510(k) NO: K010439(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 01-MAY-01
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: AQUARIUS WORKSTATION
TERARECON, INC. 510(k) NO: K011142(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 08-MAY-01
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
DEVICE: TETRAD TC-C3-ACP
TETRAD CORP. 510(k) NO: K002193(TRADITIONAL)
ATTN: DENNIS R DIETZ PHONE NO : 303-754-2320
357 INVERNESS DR. SOUTH, SE DECISION MADE: 04-MAY-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112
DEVICE: DISPOSABLE BENDING CANNULA PR-233Q
THE OLYMPUS OPTICAL CO. 510(k) NO: K011149(SPECIAL)
ATTN: LAURA STOMS-TYLER PHONE NO : 631-844-5688
ENDOSCOPE DIVISION SE DECISION MADE: 15-MAY-01
TWO CORPORATE CENTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
MELVILLE, NY 11747-3157
DEVICE: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
THE OLYMPUS OPTICAL CO. 510(k) NO: K011151(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
ENDOSCOPE DIVISION SE DECISION MADE: 15-MAY-01
TWO CORPORATE CENTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
MELVILLE, NY 11747-3157
DEVICE: TETHER ACFS
THEKEN SURGICAL,LLC 510(k) NO: K010466(TRADITIONAL)
ATTN: ROBERT THEKEN PHONE NO : 330-753-7451
1100 NOLA AVENUE SE DECISION MADE: 16-MAY-01
BARBERTON, OH 44203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
THOMSON & NIELSEN ELECTRONICS, LTD510(k) NO: K010472(TRADITIONAL)
ATTN: ANDREW HARTSHORN PHONE NO : 613 596 4563
25B NORTHSIDE RD. SE DECISION MADE: 08-MAY-01
OTTAWA, ONTARIO, CANADA K2H 8S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME
TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K002718(TRADITIONAL)
ATTN: F.W. PERRELLA PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 01-MAY-01
BEDFORD, NH 03110-5030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
TISSUELINK MEDICAL INC. 510(k) NO: K010661(TRADITIONAL)
ATTN: ROBERTA THOMPSON PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 03-MAY-01
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH
DEVICE: SKINGARD POLYCOAT GLOVE
TOP QUALITY MFG. INC. 510(k) NO: K004018(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 11-MAY-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAGUIDE MR-GUIDE 3000
ULTRAGUIDE LTD. 510(k) NO: K011418(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 24-MAY-01
HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VHF ULTRASONIC ARC-SCAN SYSTEM
ULTRALINK, LLC 510(k) NO: K003890(TRADITIONAL)
ATTN: GEORGE D WISEMAN PHONE NO : 727-527-1945
2083 HAWAII AVE N.E. SE DECISION MADE: 22-MAY-01
ST PETERSBURG, FL 33707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
USA INSTRUMENTS, INC. 510(k) NO: K010730(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 16-MAY-01
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARK 9000 PHASED ARRAY SHOULDER COIL
USA INSTRUMENTS, INC. 510(k) NO: K010946(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 30-MAY-01
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE
VAL MED CORP. 510(k) NO: K010716(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5839
555 THIRTEENTH STREET N.W. SE DECISION MADE: 30-MAY-01
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: ECLIPSE 6.5
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K010975(SPECIAL)
ATTN: LINDA NASH PHONE NO : 650-424-6990
3100 HANSEN WAY M/S F055 SE DECISION MADE: 02-MAY-01
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA ULTRASONIC NEBULIZER
VEGA TECHNOLOGIES, INC. 510(k) NO: K002831(TRADITIONAL)
ATTN: JOSEPH LU PHONE NO : 886 225 416996
11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 23-MAY-01
TAIPEI, CHINA (TAIWAN) 104 510(k) STATEMENT
DEVICE: NEUROPLUS, MODEL A10040, A10041, A10042, A10043
VERMONT MEDICAL INC. 510(k) NO: K010638(TRADITIONAL)
ATTN: MARC FILLION PHONE NO : 802-463-9976
INDUSTRIAL DR. SE DECISION MADE: 03-MAY-01
BELLOWS FALLS, VT 05101 510(k) STATEMENT
DEVICE: JEWEL MPS
VESTIL MANUFACTURING CORPORATION 510(k) NO: K011374(TRADITIONAL)
ATTN: RICK MICHAEL PHONE NO : 219-668-5677
P.O. BOX 507 SE DECISION MADE: 29-MAY-01
ANGOLA, IN 46703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
W.L. GORE & ASSOCIATES,INC 510(k) NO: K010936(TRADITIONAL)
ATTN: R. LARRY PRATT PHONE NO : 520-779-2771
3450 WEST KILTIE LANE SE DECISION MADE: 21-MAY-01
FLAGSTAFF,, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9%
WELCON, INC. 510(k) NO: K003402(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 01-MAY-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7
WESTERN ENT. 510(k) NO: K010747(TRADITIONAL)
ATTN: BYRON CRAMPTON PHONE NO : 440-871-2160
875 BASSETT RD. SE DECISION MADE: 16-MAY-01
WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM,
WHITESIDE BIOMECHANICS, INC. 510(k) NO: K003618(TRADITIONAL)
ATTN: DEBRA MEYER PHONE NO : 314-996-8540
12634 OLIVE BLVD. SE DECISION MADE: 23-MAY-01
ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
WILSON-COOK MEDICAL, INC. 510(k) NO: K011178(SPECIAL)
ATTN: MARGARET J POSNER PHONE NO : 336-774-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 04-MAY-01
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGNOST ES, MODEL 0302 0000
XMAR CORPORATION 510(k) NO: K011290(TRADITIONAL)
ATTN: NEIL BARRETT PHONE NO : 216-731-8723
2222 DELAWARE DRIVE SE DECISION MADE: 30-MAY-01
CLEVELAND HEIGHTS, OH 44106-3115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K011376(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-MAY-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 322
TOTAL WITH SUMMARIES 264
TOTAL WITH STATEMENTS 58
Updated 8/30/2001
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