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Medical Devices
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November 2007 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-NOV-2007 THROUGH 30-NOV-2007
DEVICE: THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
ABBOTT DIABETES CARE INC. 510(k) NO: K070984(TRADITIONAL)
ATTN: MARIA E TREJO PHONE NO : 510-749-6384
1360 SOUTH LOOP RD. SE DECISION MADE: 01-NOV-07
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
ABBOTT SPINE, INC. 510(k) NO: K072672(SPECIAL)
ATTN: DAVID PADGETT PHONE NO : 512-918-2700
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 28-NOV-07
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKITA2 APIXNEB
ACTIVAERO AMERICA, INC. 510(k) NO: K072019(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK SE DECISION MADE: 05-NOV-07
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134
DEVICE: MICROLUX/BLU
ADDENT, INC. 510(k) NO: K072309(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN, DDS PHONE NO : 203-778-0200
43 MIRY BROOK RD. SE DECISION MADE: 19-NOV-07
DANBURY, CT 06810 510(k) STATEMENT
DEVICE: MRI SYSTEM, MODEL MAGFINDER II / AI 3200
ADVANCED IMAGING LABORATORY 510(k) NO: K072850(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT AVE. SE DECISION MADE: 21-NOV-07
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: STERRAD 100NX STERILIZER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K071385(TRADITIONAL)
ATTN: REUBEN LAWSON PHONE NO : 949-789-8545
33 TECHNOLOGY DR. SE DECISION MADE: 29-NOV-07
IRVINE, CA 92718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
AEARO COMPANY 510(k) NO: K072359(ABBREVIATED)
ATTN: ANN L PHILLIPS PHONE NO : 508-764-5713
90 MECHANIC ST. SE DECISION MADE: 08-NOV-07
SOUTHBRIDGE, MA 01550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER TORQVUE DELIVERY SYSTEM
AGA MEDICAL CORP. 510(k) NO: K072313(TRADITIONAL)
ATTN: PATRICIA A LAFORTE PHONE NO : 763-513-9227
5050 NATHAN LANE NORTH SE DECISION MADE: 02-NOV-07
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXT GENERATION LASER
ALCON LABORATORIES 510(k) NO: K062624(TRADITIONAL)
ATTN: TERRY J DAGNON PHONE NO : 817-551-4325
6201 SOUTH FREEWAY SE DECISION MADE: 05-NOV-07
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCALERT SENSOR SYSTEM
ALERTIS MEDICAL AS 510(k) NO: K071165(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 07-NOV-07
FRIDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAD VISION, MODELS E AND EU
ALMANA MEDICAL IMAGING 510(k) NO: K072659(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 15-NOV-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K071890(TRADITIONAL)
ATTN: MARY STANNERS PHONE NO : 760-431-6771
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 09-NOV-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: VALEO PEDICLE SCREW SPINAL SYSTEM
AMEDICA CORP. 510(k) NO: K072022(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800
1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 19-NOV-07
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND
ARTHREX, INC. 510(k) NO: K072378(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 09-NOV-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSO
ARTHRO KINETICS INC. 510(k) NO: K070874(TRADITIONAL)
ATTN: JAMES HOBBS PHONE NO : 617-788-1531
8 FANEUIL HALL, 3RD FLOOR SE DECISION MADE: 02-NOV-07
BOSTON, MA 02109 510(k) STATEMENT
DEVICE: HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
ARTHROSURFACE, INC. 510(k) NO: K071413(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508-520-3003
28 FORGE PARKWAY SE DECISION MADE: 09-NOV-07
FRANKLIN, MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROYALE AE 9036 LSP INJECTOR
ASICO LLC 510(k) NO: K073010(TRADITIONAL)
ATTN: RAVI NALLAKRISHNAN PHONE NO : 630-986-8032
26 PLAZA DR. SE DECISION MADE: 07-NOV-07
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIS EEG VISTA MONITOR SYSTEM AND BISX
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K072286(TRADITIONAL)
ATTN: VIKRAM VERMA PHONE NO : 617-559-7000
1 UPLAND ROAD SE DECISION MADE: 20-NOV-07
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS
ATLANTIS COMPONENTS, INC. 510(k) NO: K072483(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 16-NOV-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERICAN HYPODERMIC NEEDLES
B. BRAUN MEDICAL, INC. 510(k) NO: K072247(TRADITIONAL)
ATTN: CHRISTINE FORD PHONE NO : 610-596-2367
901 MARCON BLVD. SE DECISION MADE: 08-NOV-07
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELUTIA ANTIMICROBIAL COATED CLOSED SURGICAL WOUND DRAIN
BACTERIN INTERNATIONAL INC. 510(k) NO: K063245(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 28-NOV-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSIO
BAXTER HEALTHCARE CORP. 510(k) NO: K072576(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
1620 WAUKEGAN RD. SE DECISION MADE: 06-NOV-07
MPGR-AL 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: BBL CHROMAGAR 0157
BECTON, DICKINSON & CO. 510(k) NO: K070691(TRADITIONAL)
ATTN: DENNIS R MERTZ PHONE NO : 410-316-4099
7 LOVETON CIR. SE DECISION MADE: 20-NOV-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K072666(TRADITIONAL)
ATTN: JAMES JOCHEN ROGERS PHONE NO : 440-546-4936
P.O. BOX 470218 SE DECISION MADE: 05-NOV-07
BROADVIEW HEIGHTS, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOXTRA MOISTURIZING GEL
BIO-X HEALTHCARE S.A. 510(k) NO: K072306(TRADITIONAL)
ATTN: EMALEE MURPHY PHONE NO : 202-778-9428
1601 K STREET NW SE DECISION MADE: 15-NOV-07
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUMEASE DENTAL MOUTHPIECE
BIOMEDEVICE LTD. 510(k) NO: K072082(TRADITIONAL)
ATTN: BRICE L YODER PHONE NO : 949-362-9407
24931 NELLIE GAIL ROAD SE DECISION MADE: 05-NOV-07
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADNET+
BIOMEDIX, INC. 510(k) NO: K073146(SPECIAL)
ATTN: WILLIAM ROGERS PHONE NO : 651-762-4010
4215 WHITE BEAR PKWY. SE DECISION MADE: 21-NOV-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
VADNAIS HEIGHTS, MN 55110
DEVICE: VITEK 2 GRAM POSITIVE TIGECYCLINE
BIOMERIEUX, INC. 510(k) NO: K072695(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 16-NOV-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
BIOMET MANUFACTURING CORP. 510(k) NO: K070015(ABBREVIATED)
ATTN: GARY E BAKER, MS RAC PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 30-NOV-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
BIOMET MANUFACTURING CORP. 510(k) NO: K072336(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 05-NOV-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
BIOMET MANUFACTURING CORP. 510(k) NO: K073102(SPECIAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 27-NOV-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVASCREW
BIORETEC LTD 510(k) NO: K072848(SPECIAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 207 789500
HERMIANKATU 22 MODULIGHT BLDG SE DECISION MADE: 02-NOV-07
TAMPERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL R
BIOSENSE WEBSTER, INC. 510(k) NO: K072202(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 909-839-7272
3333 DIAMOND CANYON RD. SE DECISION MADE: 19-NOV-07
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA SPINE SYSTEM
BK MEDITECH CO., LTD. 510(k) NO: K072436(TRADITIONAL)
ATTN: HENRY YANG PHONE NO : 949-389-9191
25041 FARRIER CIRCLE SE DECISION MADE: 01-NOV-07
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE PELVIC FLOOR REPAIR KITS
BOSTON SCIENTIFIC CORP. 510(k) NO: K071957(ABBREVIATED)
ATTN: MICHELLE BERRY PHONE NO : 508-683-4941
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 08-NOV-07
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
C.R. BARD, INC. 510(k) NO: K071365(TRADITIONAL)
ATTN: MICHELLE R GUDITH PHONE NO : 770-784-6722
8195 INDUSTRIAL BLVD. SE DECISION MADE: 06-NOV-07
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM POWERPORT ISP IMPLANTED PORT
C.R. BARD, INC. 510(k) NO: K072215(SPECIAL)
ATTN: SUSAN D SCOTT PHONE NO : 801-595-0700
605 N 5600 W SE DECISION MADE: 01-NOV-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYU
C.R. BARD, INC. 510(k) NO: K072549(SPECIAL)
ATTN: SUSAN D SCOTT PHONE NO : 801-595-0700
605 N 5600 W SE DECISION MADE: 14-NOV-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
CARDINAL HEALTH, INC. 510(k) NO: K072133(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-578-6610
1430 WAUKEGAN ROAD- MPKB-3B SE DECISION MADE: 20-NOV-07
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K072748(SPECIAL)
ATTN: JOHN CARLINE PHONE NO : 763-464-5026
18555 37TH AVE N SE DECISION MADE: 09-NOV-07
PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUFACE, MODEL NU-4003
CAROL COLE COMPANY 510(k) NO: K072260(TRADITIONAL)
ATTN: HOWARD ASHER PHONE NO : 858-259-0000
3366 N. TORREY PINES CT. SE DECISION MADE: 27-NOV-07
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: EMULATE ADVANCED
CAVEX HOLLAND B.V. 510(k) NO: K072245(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 31 235307763
HARMENJANSWEG 21 SE DECISION MADE: 08-NOV-07
HAARLEM, NETHERLANDS 2031 WH 510(k) STATEMENT
DEVICE: MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
CAYENNE MEDICAL, INC. 510(k) NO: K073054(SPECIAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 27-NOV-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
CDP, LTD. 510(k) NO: K072960(TRADITIONAL)
ATTN: DORON DAVID PHONE NO : 972 3 9191940
23 EFAL STREET SE DECISION MADE: 08-NOV-07
P.O. BOX 3325 510(k) SUMMARY AVAILABLE FROM FDA
KIRIAT ARIE, PETACH TIKVA, ISRAEL THIRD PARTY REVIEW
DEVICE: CHOY COMPRESSION FRAME
CHOY MEDICAL TECHNOLOGIES, INC. 510(k) NO: K070968(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5894
555 THIRTEENTH STREET NW SE DECISION MADE: 15-NOV-07
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRA
CHURCH & DWIGHT CO., INC. 510(k) NO: K073016(ABBREVIATED)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748
469 NORTH HARRISON STREET SE DECISION MADE: 09-NOV-07
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSPONGE PLUS SYSTEM
CLEARCOUNT MEDICAL SOLUTIONS, INC.510(k) NO: K073180(TRADITIONAL)
ATTN: ROBERT MARSHALL PHONE NO : 724-352-8000
491 CHANTLER DRIVE SE DECISION MADE: 19-NOV-07
SAXONBURG, PA 16056 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COLLIMARE "COLLIMATOR FAMILY"
COLLIMARE, LLC 510(k) NO: K073124(ABBREVIATED)
ATTN: HOWARD C THOMAS PHONE NO : 303-955-3091
13406 W 60TH PL SE DECISION MADE: 16-NOV-07
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPEEDICATH COMPACT
COLOPLAST CORP. 510(k) NO: K072808(TRADITIONAL)
ATTN: REBEKA STOLTMAN PHONE NO : 612-302-4997
1601 WEST RIVER N SE DECISION MADE: 09-NOV-07
MINNEAPOLIS, MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUO TEMP
COLTENE/WHALEDENT AG 510(k) NO: K072604(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVENUE SE DECISION MADE: 16-NOV-07
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: CTU676 DEVICE
COMPRESSION TECHNOLOGIES UNLIMITED510(k) NO: K073013(TRADITIONAL)
ATTN: DOUGLASS HALE PHONE NO : 517-420-8204
12080 DAWNHAVEN AVE. SE DECISION MADE: 21-NOV-07
LANSING, MI 48917 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONFIDANT 2.5
CONFIDANT INC. 510(k) NO: K072698(TRADITIONAL)
ATTN: DANIEL R PLONSKI PHONE NO : 919-806-4323
2530 MERIDIAN PARKWAY SE DECISION MADE: 16-NOV-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
DURHAM, NC 27713
DEVICE: CONFORMIS UNI-CONDYLAR KNEE SYSTEM
CONFORMIS, INC. 510(k) NO: K072586(TRADITIONAL)
ATTN: S. MICHAEL SHARP PHONE NO : 781-860-5111
2 FOURTH AVENUE SE DECISION MADE: 08-NOV-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
COOK UROLOGICAL, INC. 510(k) NO: K072521(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4691
1100 WEST MORGAN ST. SE DECISION MADE: 20-NOV-07
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUNTER TULIP VENA CAVA FILTER
COOK, INC. 510(k) NO: K072240(SPECIAL)
ATTN: MOLLY BUSENBARK PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 08-NOV-07
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CXI SUPPORT CATHETER
COOK, INC. 510(k) NO: K072724(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686
750 DANIELS WAY PO BX 489 SE DECISION MADE: 09-NOV-07
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE LIFE VESSEL
COTTONWOOD VESSEL CORPORATION 510(k) NO: K070690(TRADITIONAL)
ATTN: MIKI KOLTON PHONE NO : 202-331-3134
800 CONNECTICUT AVE., NW SE DECISION MADE: 16-NOV-07
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDL
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K073122(ABBREVIATED)
ATTN: DEBORA STAPLETON PHONE NO : 508-452-4866
15 HAMPSHIRE ST. SE DECISION MADE: 21-NOV-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE II LASER
CYNOSURE, INC. 510(k) NO: K072868(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 05-NOV-07
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES A
DADE BEHRING, INC. 510(k) NO: K071224(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 SE DECISION MADE: 13-NOV-07
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: I LIGHT
DENT'N CO 510(k) NO: K072807(ABBREVIATED)
ATTN: ALAN DONALD PHONE NO : 858-485-8584
11440 WEST BERNARDO CT. SE DECISION MADE: 21-NOV-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92127
DEVICE: IMPLANTIUM PROSTHETICS
DENTIUM CO., LTD. 510(k) NO: K070228(SPECIAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DR SE DECISION MADE: 20-NOV-07
ATLANTA, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOFORM SHEET MATERIALS AND ACCESSORIES
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072522(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. SE DECISION MADE: 16-NOV-07
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY SPA POROUS COATED PROXIMAL SLEEVE
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071059(TRADITIONAL)
ATTN: KATHY HARRIS PHONE NO : 574-372-7082
P.O. BOX 988 SE DECISION MADE: 09-NOV-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM C
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K072423(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-328-3851
700 ORTHOPAEDIC DR. SE DECISION MADE: 07-NOV-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K071927(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DRIVE SE DECISION MADE: 21-NOV-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
DERMA SCIENCES, INC. 510(k) NO: K072956(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 07-NOV-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
DERMAPORT, INC 510(k) NO: K071202(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 30-NOV-07
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SM INTERNAL./EXTERNAL IMPLANT SYSTEM
DIO DEPARTMENT DSI, INC. 510(k) NO: K070569(TRADITIONAL)
ATTN: KENNY LIM PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD SE DECISION MADE: 08-NOV-07
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M
DOOYANG SYSTEMS INC 510(k) NO: K072532(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 02-NOV-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-SPECT
EAGLE HEART IMAGING, LLC 510(k) NO: K073021(TRADITIONAL)
ATTN: JOHN KOSS PHONE NO : 303-426-8388
8407 BRYANT ST. SE DECISION MADE: 06-NOV-07
WESTMINSTER, CO 80031-3809 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EARLYSENSE ES-16 SYSTEM
EARLYSENSE LTD. 510(k) NO: K070375(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 361 23281
7, JABOTINSKY ST. SE DECISION MADE: 15-NOV-07
RAMAT GAN, ISRAEL 52520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HABIB ENDOBLATE
EMCISION, LTD. 510(k) NO: K072383(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO :
LIVER SURGERY, HAMMERSMITH SE DECISION MADE: 29-NOV-07
HOSPITAL CAMPUS, DU CANE RD. 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UK, UNITED KINGDOM W12 OHSTHIRD PARTY REVIEW
DEVICE: HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
EMPI 510(k) NO: K072946(SPECIAL)
ATTN: SANDRA WALROD PHONE NO : 651-415-7344
599 CARDIGAN RD. SE DECISION MADE: 16-NOV-07
ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENDYS, MODEL 6000 B B/C
ENDOTHELIX, INC. 510(k) NO: K072919(SPECIAL)
ATTN: DOUG BLAKELY PHONE NO : 210-240-4521
8275 EL RIO SE DECISION MADE: 02-NOV-07
SUITE 100 510(k) STATEMENT
HOUSTON, TX 77054
DEVICE: VIAPEEL PEELABLE INTRODUCER
ENPATH MEDICAL, INC. 510(k) NO: K072248(SPECIAL)
ATTN: PATRICE STROMBERG PHONE NO : 763-951-8244
2300 BERKSHIRE LANE NORTH SE DECISION MADE: 09-NOV-07
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOELAST 5-0 SUTURE, MODEL 500100
ENTRIGUE SURGICAL, INC. 510(k) NO: K072470(TRADITIONAL)
ATTN: GABRIELE NIEDERAUER PHONE NO : 210-582-5827
3463 MAGIC DRIVE, SUITE 320 SE DECISION MADE: 16-NOV-07
SAN ANTONIO, TX 78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAP PLUS
ETEX CORP. 510(k) NO: K063050(TRADITIONAL)
ATTN: FRANCES A FLORENCE PHONE NO : 617-577-7270
38 SIDNEY ST., 3FLR SE DECISION MADE: 19-NOV-07
THE CLARK BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
EVERLIFE MEDICAL EQUIPMENT CO., LT510(k) NO: K071624(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 27-NOV-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
FAMIDOC TECHNOLOGY CO., LTD 510(k) NO: K072641(TRADITIONAL)
ATTN: STEELJIN PHONE NO : 867 552 7864337
6/F,G BUILDING 14 LIUXIAN 1ST SE DECISION MADE: 01-NOV-07
RD 71 BLOCK BAOAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENZHEN GUANGDONG,PR, CHINA THIRD PARTY REVIEW
DEVICE: THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
FOX HOLLOW TECHNOLOGIES 510(k) NO: K071826(SPECIAL)
ATTN: SRIDEVI SHESHADRI PHONE NO : 650-839-7996
740 BAY ROAD SE DECISION MADE: 09-NOV-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALEMED CPAP MASK
GALEMED CORP. 510(k) NO: K072755(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT SE DECISION MADE: 16-NOV-07
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
GAMBRO, INC. 510(k) NO: K070643(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 W. COLLINS AVE. SE DECISION MADE: 02-NOV-07
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRADWEB PACS SYSTEM
GE HEALTHCARE 510(k) NO: K072986(SPECIAL)
ATTN: JILLIAN M REED PHONE NO : 203-459-0659
25 WALNUT STREET SE DECISION MADE: 20-NOV-07
MONROE, CT 06468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K072502(SPECIAL)
ATTN: PATRICIA TAIGE PHONE NO : 414-721-3222
9900 INNAVATION DR. SE DECISION MADE: 19-NOV-07
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESCAPE V100
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K073203(SPECIAL)
ATTN: KAREN RUSSELL PHONE NO : 503-831-3176
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 29-NOV-07
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
GE MEDICAL SYSTEMS, LLC 510(k) NO: K072998(TRADITIONAL)
ATTN: MARK M STAUFFER PHONE NO : 262-521-6891
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 01-NOV-07
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE ECHOPAC
GENERAL ELECTRIC CO. 510(k) NO: K072952(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 16-NOV-07
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTIAN CYSTATIN C IMMUNOASSAY
GENTIAN AS 510(k) NO: K071388(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 06-NOV-07
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYN DISPOSABLES TENACULUM 356T
GYN-DISPOSABLES, INC. 510(k) NO: K073182(TRADITIONAL)
ATTN: JAMES K PATTERSON PHONE NO : 901-372-6181
2671 APPLING ROAD SE DECISION MADE: 28-NOV-07
MEMPHIS, TN 38133-5001 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HAMILTON-G5
HAMILTON MEDICAL AG 510(k) NO: K070513(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 418 166 06479
VIA CRUSCH 8 SE DECISION MADE: 26-NOV-07
BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-CATH POLY PICC
HDC CORP. 510(k) NO: K071875(TRADITIONAL)
ATTN: EARL SMART PHONE NO : 408-942-7340
628 GIBRALTAR CT. SE DECISION MADE: 05-NOV-07
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K072593(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 15-NOV-07
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIO ACUPUNCTURE NEEDLES
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K072778(TRADITIONAL)
ATTN: YUKUO HSU PHONE NO : 408-433-3355
606 CHARCOT AVE. SE DECISION MADE: 19-NOV-07
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: ACCESSA CHOLESTEROL PANEL
HOME ACCESS HEALTH CORP. 510(k) NO: K063852(TRADITIONAL)
ATTN: KAREN L HANSON PHONE NO : 847-781-2522
2401 W. HASSELL SE DECISION MADE: 09-NOV-07
SUITE 1510 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60195-5200
DEVICE: ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N
HORIBA ABX 510(k) NO: K072115(TRADITIONAL)
ATTN: OLIVIER DUCAMP PHONE NO : 33 4 67147392
PARC EUROMEDECINE SE DECISION MADE: 30-NOV-07
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: MOBIL-O-GRAPH NG 24 H ABP-CONTROL
I.E.M. GMBH 510(k) NO: K072446(SPECIAL)
ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 29-NOV-07
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UN
IMIX ADR FINLAND OY 510(k) NO: K072867(SPECIAL)
ATTN: JAMES TAYLOR PHONE NO : 802-244-5654
75 ORCHARD SPRING ESTS SE DECISION MADE: 21-NOV-07
WATERBURY, VT 05676 510(k) STATEMENT
DEVICE: RIGI-FIX HIP STEM SYSTEM
IMPLANTS INTL. LTD. 510(k) NO: K072101(TRADITIONAL)
ATTN: MOHAN EMMANUEL PHONE NO : 44 784 3380023
71 JAY AVE. SE DECISION MADE: 19-NOV-07
TEESSIDE INDUSTRIAL EST. 510(k) SUMMARY AVAILABLE FROM FDA
THORNABY-ON-TEES, UNITED KINGDOM T517 9LZ
DEVICE: FUNHALER, MODEL V-201E
INFAMED LTD. 510(k) NO: K072822(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 26-NOV-07
SOUTHWEST RANCHES, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY
INNOVA VISION INC. 510(k) NO: K073060(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DRIVE SE DECISION MADE: 29-NOV-07
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), E
INNOVASIS, INC. 510(k) NO: K071921(SPECIAL)
ATTN: WARREN DANSIE PHONE NO : 801-261-2236
614 EAST 3900 SOUTH SE DECISION MADE: 16-NOV-07
SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IST ANTERIOR CERVICAL PLATE SYSTEM
INNOVATIVE SPINAL TECHNOLOGIES INC510(k) NO: K072650(TRADITIONAL)
ATTN: GINA YEH PHONE NO : 508-452-3500
111 FORBES BLVD. SE DECISION MADE: 28-NOV-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
INVACARE CORPORATION 510(k) NO: K073134(SPECIAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 16-NOV-07
ELYRIA, OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTCHECK INR SYSTEM
INVERNESS MEDICAL INNOVATIONS, INC510(k) NO: K071265(TRADITIONAL)
ATTN: LESLEY MOORE PHONE NO : 781-314-4185
51 SAWYER RD., SUITE 200 SE DECISION MADE: 30-NOV-07
WALTHAM, MA 02453-3448 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LBS-63-16 BREAST ARRAY COIL
INVIVO 510(k) NO: K072873(SPECIAL)
ATTN: JEFF WILKINSON PHONE NO : 352-336-0010
3545 S.W. 47TH AVE. SE DECISION MADE: 16-NOV-07
GAINESVILLE, FL 32608 510(k) STATEMENT
DEVICE: LBS-127-16 BREAST ARRAY COIL
INVIVO 510(k) NO: K072874(SPECIAL)
ATTN: JEFF WILKINSON PHONE NO : 352-336-0010
3545 S.W. 47TH AVE. SE DECISION MADE: 16-NOV-07
GAINESVILLE, FL 32608 510(k) STATEMENT
DEVICE: BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
JAWON MEDICAL CO., LTD. 510(k) NO: K072325(TRADITIONAL)
ATTN: HL JUNG PHONE NO : 2 626 49001
ROOM 624, LIFE OFFICETEL, 61-3 SE DECISION MADE: 30-NOV-07
YOIDO-DONG, YOUNGDEUNGPO-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, KOREA, REPUBLIC OF KOREA 150-731
DEVICE: KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K072216(SPECIAL)
ATTN: ALBERT N SANTILLI PHONE NO : 216-587-4400
4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 09-NOV-07
WARRENSVILLE HEIGHTS, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIM-PC, MODEL 1010
KARMEL SONIX 510(k) NO: K071955(SPECIAL)
ATTN: YORAM LEVY PHONE NO : 972 4 6388837
31 HAAVODA ST. SE DECISION MADE: 01-NOV-07
BINYAMINA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERCABLE GRIP AND PLATE SYSTEM
KINAMED, INC. 510(k) NO: K072250(TRADITIONAL)
ATTN: VINEET K SARIN PHONE NO : 805-384-2748
820 FLYNN RD. SE DECISION MADE: 09-NOV-07
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND
KIRCHNER & WILHELM GMBH + CO.KG 510(k) NO: K070270(TRADITIONAL)
ATTN: NATALYA VALERIO PHONE NO : 516-482-9001
55 NORTHERN BLVD, SUITE 200 SE DECISION MADE: 05-NOV-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODELS EMS 5.0, EMS 5.1
KOALATY PRODUCTS, INC. 510(k) NO: K072795(TRADITIONAL)
ATTN: JEFF LENOIR PHONE NO : 813-871-5901
5015 N. CLARK AVE. SE DECISION MADE: 27-NOV-07
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUSCO ES-3100
KORATEK COMPANY, LTD. 510(k) NO: K070550(TRADITIONAL)
ATTN: PAUL SUMNER PHONE NO : 770-448-7529
1733 CANTON LANE SE DECISION MADE: 06-NOV-07
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K072135(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 07-NOV-07
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REP
LANG DENTAL MFG. CO., INC. 510(k) NO: K072580(TRADITIONAL)
ATTN: CHAH SHEN PHONE NO : 847-215-6622
175 MESSNER DR. SE DECISION MADE: 05-NOV-07
WHEELING, IL 60090-0969 510(k) STATEMENT
DEVICE: IMPLUS IMPLANT SYSTEM
LEADER ITALIA S.R.L. 510(k) NO: K062931(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVE. SE DECISION MADE: 28-NOV-07
NEW YORK, NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT AND VARIOUS OTHER TRADENAMES
LEONHARD LANG GMBH 510(k) NO: K073104(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-NOV-07
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
LIFECORE BIOMEDICAL, INC. 510(k) NO: K072241(ABBREVIATED)
ATTN: JUDITH MEDLOCK-HAYES PHONE NO : 952-368-4300
3515 LYMAN BLVD. SE DECISION MADE: 09-NOV-07
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
LIFECORE BIOMEDICAL, INC. 510(k) NO: K073032(SPECIAL)
ATTN: JUDITH MEDLOCK-HAYES PHONE NO : 952-368-4300
3515 LYMAN BLVD. SE DECISION MADE: 16-NOV-07
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE
LIFESCIENCE PLUS, INC. 510(k) NO: K072681(TRADITIONAL)
ATTN: AUDRY VITALE PHONE NO : 860-536-4427
22 STONY HILL DRIVE SE DECISION MADE: 02-NOV-07
MYSTIC, CT 06355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-
LYNTON LASERS LIMITED 510(k) NO: K072048(TRADITIONAL)
ATTN: ANDREW JOHN BERRY PHONE NO : 44 147 7536977
LYNTON HOUSE, MANOR LANE SE DECISION MADE: 16-NOV-07
HOLMES CHAPEL, CHESHIRE, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESLA GUARD, MODEL EFT G04
MAMMENDORFER INSTITUT FUR PHYSIK U510(k) NO: K071802(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 W. 7TH AVE. SE DECISION MADE: 09-NOV-07
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL N
MEDCOMP 510(k) NO: K072509(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 26-NOV-07
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIAID PULSE OXIMETER M30 AND M34
MEDIAID INC. 510(k) NO: K071610(TRADITIONAL)
ATTN: JAYESH PATEL PHONE NO : 714-367-2848
17517 FABRICA WAY, SUITE H SE DECISION MADE: 05-NOV-07
CERRITOS, CA 90703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTBLOCK PAIN PUMP
MEDICAL FLOW SYSTEMS LTD 510(k) NO: K072053(TRADITIONAL)
ATTN: MARK DOLLINGER PHONE NO : 913-317-8788
2940 WEST 123RD TERRACE SE DECISION MADE: 06-NOV-07
LEAWOOD, KS 66200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOL INJECTOR SET
MEDICEL AG 510(k) NO: K070669(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 01-NOV-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SA-3000P
MEDICORE CO., LTD. 510(k) NO: K073323(TRADITIONAL)
ATTN: YOO BYUNG-KUK PHONE NO : 832 205 62650
4F LUNA B/D SE DECISION MADE: 29-NOV-07
72-3 CHUNGDAM-DONG 510(k) SUMMARY AVAILABLE FROM FDA
GANGNAM-GU, SEOUL, REPUBLIC OF KORTHIRD PARTY REVIEW
DEVICE: MEDSTREAMING MEDICAL OFFICE SOFTWARE
MEDSTREAMING, LLC 510(k) NO: K072972(TRADITIONAL)
ATTN: KARLA PATTEN PHONE NO : 425-239-1240
540 240TH AVENUE SE SE DECISION MADE: 06-NOV-07
SAMMAMISH, WA 98074 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSI
MEDTRONIC INC. 510(k) NO: K071641(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-526-2342
8200 CORAL SEA STREET NW SE DECISION MADE: 21-NOV-07
MOUNDS VIEW, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT,
MEDTRONIC INC. 510(k) NO: K071655(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-526-2342
8200 CORAL SEA STREET NW SE DECISION MADE: 21-NOV-07
MOUNDS VIEW, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT PUTTY
MEDTRONIC SOFAMOR DANEK 510(k) NO: K071813(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-NOV-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K071416(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 01-NOV-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
MEDTRONIC VASCULAR 510(k) NO: K062264(TRADITIONAL)
ATTN: DAVID W GARCIA PHONE NO : 707-591-2532
3576 UNOCAL PL. SE DECISION MADE: 08-NOV-07
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
MEGO AFEK 510(k) NO: K072372(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 21-NOV-07
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: VITALOGIK MODEL 4000/4500
MENNEN MEDICAL LTD. 510(k) NO: K073140(SPECIAL)
ATTN: IFAT OREN PHONE NO : 972 8 9323333
4 HAYARDEN ST., YAVNE SE DECISION MADE: 21-NOV-07
P.O.BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: TRU FLU
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K071657(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 15-NOV-07
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE BILIARY DRAINAGE CATHETER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K063733(TRADITIONAL)
ATTN: AMY MCKINNEY PHONE NO : 713-757-5909
1600 WEST MERIT PKWY. SE DECISION MADE: 14-NOV-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSTASIS VALVE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K072556(TRADITIONAL)
ATTN: SHIRLEY HYINK PHONE NO : 801-208-4795
1600 WEST MERIT PKWY. SE DECISION MADE: 20-NOV-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K073035(SPECIAL)
ATTN: SHIRLEY HYINK PHONE NO : 801-208-4795
1600 WEST MERIT PKWY. SE DECISION MADE: 20-NOV-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONDEAL EXTREMITY BONE FIXATION SYSTEM
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K072740(TRADITIONAL)
ATTN: JAY EVANS PHONE NO : 858-901-4123
P.O. BOX 500521 SE DECISION MADE: 19-NOV-07
SAN DIEGO, CA 92150-0521 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEF TUBE
N.M. BEALE CO. INC. 510(k) NO: K071579(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENEUE SE DECISION MADE: 20-NOV-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
NEOCOIL 510(k) NO: K073236(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262-347-1250
N27 W23910A PAUL RD. SE DECISION MADE: 30-NOV-07
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
NEOCOIL, LLC 510(k) NO: K073181(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262-347-1250
N27 W23910A PAUL RD. SE DECISION MADE: 21-NOV-07
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SATURN 9000-750
NEW MEDICAL CO., LTD. 510(k) NO: K072983(SPECIAL)
ATTN: YOUNG-HOON SHIN PHONE NO : 886 287 916268
4F, NO.42, SINGZHONG RD. SE DECISION MADE: 13-NOV-07
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: SATURN 9000-550
NEW MEDICAL CO., LTD. 510(k) NO: K072984(SPECIAL)
ATTN: YOUNG-HOON SHIN PHONE NO : 886 287 916268
4F, NO.42, SINGZHONG RD. SE DECISION MADE: 14-NOV-07
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: NEXFIX COMPRESSION PIN
NEXA ORTHOPEDICS, INC. 510(k) NO: K072710(TRADITIONAL)
ATTN: COREY WILSON-WIRTH PHONE NO : 858-866-0660
11035 ROSELLE STREET SE DECISION MADE: 08-NOV-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YG-125T AND YG-135T NASAL ADAPTER
NIHON KOHDEN AMERICA, INC. 510(k) NO: K072843(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 29-NOV-07
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEON, MODEL LS1100-01-0968
NOMIR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K071815(TRADITIONAL)
ATTN: RICHARD BURTT PHONE NO : 617-901-6637
275 GROVE ST, SUITE 2-400 SE DECISION MADE: 28-NOV-07
NEWTON, MA 02466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FMRI HARDWARE SYSTEM
NORDICNEUROLAB 510(k) NO: K073099(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE NE SE DECISION MADE: 20-NOV-07
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISPENSER DP 20
NOUVAG AG 510(k) NO: K071588(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 415 620 19500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 26-NOV-07
GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY FLUORESCENT IMAGING SYSTEM
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K071619(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822
2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 09-NOV-07
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-D
OLYMPUS CORPORATION 510(k) NO: K072643(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 011 813 38188577
4-2-1 YUSHIMA, BUNKYO-KU SE DECISION MADE: 16-NOV-07
TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
OSCOR INC. 510(k) NO: K073100(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 30-NOV-07
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: GS FIXTURE SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K072896(SPECIAL)
ATTN: KIM M JOO PHONE NO : 215-736-2990
ONE BEN FAIRLESS DR. SE DECISION MADE: 06-NOV-07
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTODYNAMICS OTOPORT
OTODYNAMICS, LTD. 510(k) NO: K072033(TRADITIONAL)
ATTN: CHRISTINA NORRIS PHONE NO : 410-451-0639
1676 VILLAGE GREEN SE DECISION MADE: 13-NOV-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CROFTON, MD 21114
DEVICE: ERBIUM FRACTIONAL HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K071768(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 617-957-1434
82 CAMBRIDGE ST. SE DECISION MADE: 05-NOV-07
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: PARI HYDRATE V
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K072982(TRADITIONAL)
ATTN: MIKE JUDGE PHONE NO : 804-253-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 29-NOV-07
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GENERATION 8 SE ADHESIVE
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K072480(TRADITIONAL)
ATTN: GREG MARCEAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 21-NOV-07
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: PFM PICC
PFM MEDICAL, INC 510(k) NO: K072391(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 19-NOV-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056
DEVICE: IMMUNOCAP THYRLOBULIN IMMUNOCAP
PHADIA US INC. 510(k) NO: K072661(SPECIAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 20-NOV-07
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553
POSSIS MEDICAL, INC. 510(k) NO: K072769(TRADITIONAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 14-NOV-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMUS A1CARE ASSAY
PRIMUS CORP. 510(k) NO: K062658(TRADITIONAL)
ATTN: BRITT EINSPAHR PHONE NO : 800-377-4752
4231 E. 75TH TERRACE SE DECISION MADE: 26-NOV-07
KANSAS CITY, MO 64132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR
PRINCETON BIOMEDITECH CORP. 510(k) NO: K062575(TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 26-NOV-07
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
R & D SYSTEMS, INC. 510(k) NO: K072268(TRADITIONAL)
ATTN: NANCY C RING PHONE NO : 612-656-4533
614 MCKINLEY PL., N.E. SE DECISION MADE: 20-NOV-07
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
R & D SYSTEMS, INC. 510(k) NO: K072846(TRADITIONAL)
ATTN: NANCY C RING PHONE NO : 612-656-4533
614 MCKINLEY PL., N.E. SE DECISION MADE: 26-NOV-07
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
RALCO S.R.L. 510(k) NO: K072780(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 26-NOV-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXIT
RAPID INJECTION SYSTEMS CORP. 510(k) NO: K072479(TRADITIONAL)
ATTN: SOL SOROCA PHONE NO : 516-746-2622
30 NORTHPORT RD. SE DECISION MADE: 09-NOV-07
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: FRAXEL III SR LASER SYSTEM AND ACCESSORIES
RELIANT TECHNOLOGIES, INC. 510(k) NO: K071051(TRADITIONAL)
ATTN: HEATHER MACFALLS PHONE NO : 650-605-2257
464 ELLIS ST. SE DECISION MADE: 02-NOV-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
REMEL, INC. 510(k) NO: K072827(TRADITIONAL)
ATTN: ANDRE HSIUNG PHONE NO : 913-895-4264
12076 SANTA FE DR. SE DECISION MADE: 26-NOV-07
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
RENU MEDICAL, INC. 510(k) NO: K072194(TRADITIONAL)
ATTN: BRUCE PIERSON PHONE NO : 425-353-1110
9800 EVERGREEN WAY SE DECISION MADE: 29-NOV-07
EVERETT, WA 98204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT300-S AND RT300-SP FES CYCLE ERGOMETER
RESTORATIVE THERAPIES INC. 510(k) NO: K072398(TRADITIONAL)
ATTN: ANDREW BARRISKILL PHONE NO : 800-609-9166
907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 21-NOV-07
BALTIMORE, MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
SABLE INDUSTRIES, INC. 510(k) NO: K072554(ABBREVIATED)
ATTN: KEVIN RANDALL PHONE NO : 303-828-0844
581 WHILES COURT SE DECISION MADE: 14-NOV-07
ERIE, CO 80516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT CENTER
SATELEC-ACTEON GROUP 510(k) NO: K072030(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 19-NOV-07
MT LAUREL, NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
SATYRNE MEDICAL 510(k) NO: K072463(TRADITIONAL)
ATTN: SCOTT LOVALD PHONE NO : 505-620-3856
1909 GOLD AVE. SE # 1 SE DECISION MADE: 29-NOV-07
ALBUQUERQUE, NM 87106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCHICK COMPUTED ORAL RADIOLOGY SYSTEM
SCHICK TECHNOLOGIES, INC. 510(k) NO: K072134(SPECIAL)
ATTN: DANIEL MITCHELL PHONE NO : 718-937-5765
30-30 47TH AVE. SE DECISION MADE: 02-NOV-07
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUYUAN LATEX EXAMINATION GLOVE, POWDERED
SHANDONG YUYUAN LATEX GLOVES COMPA510(k) NO: K072639(TRADITIONAL)
ATTN: JESSIE SUN PHONE NO : 86 635 2423190
1296 INDUSTRIAL PARK SE DECISION MADE: 19-NOV-07
LINQING CITY, SHANDONG, CHINA 2526510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM SERIES PATIENT MONITORS, MODELS: PM-9000 EXPRESS, PM-8000 EXP
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K072346(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-NOV-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2500 OM-MA, MODEL L5KOP
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K072794(SPECIAL)
ATTN: MAYA MAHUE-GIANGRECO PHONE NO : 310-645-8200
5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 05-NOV-07
LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULARIS VARIOSTAR
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K070799(TRADITIONAL)
ATTN: KIM RENDON PHONE NO : 610-448-1773
51 VALLEY STREAM PARKWAY SE DECISION MADE: 01-NOV-07
MS E50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: ACUSON S2000 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072786(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650-694-5988
1230 SHOREBIRD WAY SE DECISION MADE: 13-NOV-07
MOUNTAIN VIEW, CA 94039 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FIDELITY 200 CARDIAC EVENT RECORDER
SIGNALIFE, INC. 510(k) NO: K071228(ABBREVIATED)
ATTN: WILLIAM MATTHEWS PHONE NO : 864-233-2300
531 SOUTH MAIN ST. SE DECISION MADE: 21-NOV-07
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
GREENVILLE, SC 29601
DEVICE: POLYGRAFT BGS
SMITH & NEPHEW, INC. 510(k) NO: K062607(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 09-NOV-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE
SMITH & NEPHEW, INC. 510(k) NO: K072818(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 19-NOV-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TC-PLUS PRIMARY KNEE SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K072858(ABBREVIATED)
ATTN: RISHI SINHA PHONE NO : 901-399-6054
1450 BROOKS RD. SE DECISION MADE: 20-NOV-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEA
SMITHS MEDICAL ASD, INC. 510(k) NO: K071958(TRADITIONAL)
ATTN: CHRISTINE LLOYD PHONE NO : 781-878-8011
160 WEYMOUTH ST. SE DECISION MADE: 21-NOV-07
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTIV SAFETY I.V. CATHETER
SMITHS MEDICAL ASD, INC. 510(k) NO: K072419(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-791-5568
6250 SHIER RINGS RD. SE DECISION MADE: 09-NOV-07
DUBLIN, OH 43016 510(k) STATEMENT
DEVICE: HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
SMITHS MEDICAL ASD, INC. 510(k) NO: K072482(TRADITIONAL)
ATTN: BRIAN FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 29-NOV-07
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MOD
SMITHS MEDICAL ASD, INC. 510(k) NO: K072783(TRADITIONAL)
ATTN: BRIAN FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 30-NOV-07
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIPPER MICRO NEEDLE
SMITHS MEDICAL MD, INC. 510(k) NO: K072059(TRADITIONAL)
ATTN: BRIAN L HAUGSTAD PHONE NO : 651-628-7513
1265 GREY FOX RD. SE DECISION MADE: 01-NOV-07
ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO 225 DUAL HALOGEN LIGHT SOURCE
SOPRO 510(k) NO: K072912(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 16-NOV-07
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM
SOUTHERN IMPLANTS, INC. 510(k) NO: K071161(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10355 B DEMOCRACY LANE SE DECISION MADE: 16-NOV-07
FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCENT
SPINAL ELEMENTS, INC. 510(k) NO: K071724(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 09-NOV-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSION BAND ANTERIOR SPINAL SYSTEM
SPINAL INSTRUMENTATION SIMPLIFICAT510(k) NO: K071151(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 07-NOV-07
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEFRONTIER DORADO VBR
SPINEFRONTIER, INC. 510(k) NO: K072289(TRADITIONAL)
ATTN: TOM CARLSON PHONE NO : 978-232-3990
100 CUMMINGS CENTER SE DECISION MADE: 01-NOV-07
SUITE 240C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: ODYSSEY WORKSTATION
STEREOTAXIS, INC. 510(k) NO: K072371(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 314-678-6136
4320 FOREST PARK AVENUE SE DECISION MADE: 14-NOV-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63108
DEVICE: VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR
STERIS CORPORATION 510(k) NO: K071895(ABBREVIATED)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 14-NOV-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER STRI-SHIELD FLYTE TOGAS
STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K073017(SPECIAL)
ATTN: PAULETTE D JOHNSON PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 30-NOV-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T.B.R. ZIRCONNECT
SUDIMPLANT SA 510(k) NO: K070935(ABBREVIATED)
ATTN: DIDIER SAILHAN PHONE NO : 33 5 62167100
24 IMPASSE RENE COUZINET SE DECISION MADE: 09-NOV-07
PARC DE LA PLAINE 510(k) SUMMARY AVAILABLE FROM FDA
TOULOUSE, FRANCE 31500
DEVICE: DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
SYMBIOS MEDICAL PRODUCTS, LLC 510(k) NO: K072921(SPECIAL)
ATTN: JEFFREY ALHOLM PHONE NO : 317-225-4447
7301 GEORGETOWN RD SE DECISION MADE: 26-NOV-07
SUITE 150 510(k) STATEMENT
INDIANAPOLIS, IN 46268-4194
DEVICE: SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
SYNTHES (USA) 510(k) NO: K072578(TRADITIONAL)
ATTN: SHERI MUSGNUNG PHONE NO : 610-719-6940
1302 WRIGHTS LANE EAST SE DECISION MADE: 28-NOV-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES VECTRA-ONE SYSTEM
SYNTHES SPINE 510(k) NO: K071667(TRADITIONAL)
ATTN: STACEY BONNELL PHONE NO : 610-719-5895
1302 WRIGHTS LANE EAST SE DECISION MADE: 30-NOV-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX XE-5000
SYSMEX AMERICA, INC. 510(k) NO: K071967(TRADITIONAL)
ATTN: NINA M GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 20-NOV-07
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCA-CHEK
TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K071711(TRADITIONAL)
ATTN: CHARLES PENNINGTON PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 07-NOV-07
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEPHAFLEX SURGICAL FILM
TEPHA, INC. 510(k) NO: K072520(TRADITIONAL)
ATTN: MARY LEGRAW PHONE NO : 781-357-1709
99 HAYDEN, SUTIE 360 SE DECISION MADE: 29-NOV-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K071521(TRADITIONAL)
ATTN: MARK A BUR PHONE NO : 734-741-6117
6200 JACKSON RD. SE DECISION MADE: 21-NOV-07
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V. 510(k) NO: K072894(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 003 216 381211
RESEARCHPARK ZONE 2 SE DECISION MADE: 06-NOV-07
INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN, BELGIUM 3001
DEVICE: TEXTRONICS ECG ELECTRODE
TEXTRONICS, INC 510(k) NO: K071576(TRADITIONAL)
ATTN: JANICE HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET SE DECISION MADE: 02-NOV-07
PHILADEPHIA, PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR US
THE BINDING SITE, LTD. 510(k) NO: K070900(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 30-NOV-07
2425 WEST OLYMPIC BOULEVARD 510(k) SUMMARY AVAILABLE FROM FDA
SANTA MONICA, CA 90404
DEVICE: THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYST
THERATEST LABORATORIES, INC. 510(k) NO: K071692(TRADITIONAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630-627-6069
1111 N. MAIN ST. SE DECISION MADE: 05-NOV-07
LOMBARD, IL 60148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
THERMOGEAR, INC. 510(k) NO: K071918(TRADITIONAL)
ATTN: WAYNE FIELDS PHONE NO : 503-697-1900
16337 SW BRYANT RD. SE DECISION MADE: 09-NOV-07
PO BOX 1545 510(k) SUMMARY AVAILABLE FROM FDA
LAKE OSWEGO, OR 97035 THIRD PARTY REVIEW
DEVICE: VASCUTRAK II PTA DILATATION CATHETER
THERMOPEUTIX INC. DBA YMED INC. 510(k) NO: K073025(SPECIAL)
ATTN: THOMAS SCHROEDER PHONE NO : 858-549-1760
9925B BUSINESS PARK AVE. SE DECISION MADE: 09-NOV-07
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI CONTACT PLATFORM O 4.0 MM
THOMMEN MEDICAL, AG 510(k) NO: K072933(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 15-NOV-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: CSNP-001A NEURO PACKAGE
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K072693(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 01-NOV-07
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K073081(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 21-NOV-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: DRAD-3000E, RADREX-I
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K073165(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 16-NOV-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 3S HEMI TOE
TRILLIANT SURGICAL LTD 510(k) NO: K072922(TRADITIONAL)
ATTN: JD WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 28-NOV-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPA AMD ANTIMICROBIAL WOUND DRESSING
TYCO HEALTHCARE GROUP, LP 510(k) NO: K071371(TRADITIONAL)
ATTN: JAMES WALSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 19-NOV-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIDUS MAGNUM MALE LATEX CONDOM
UNIDUS CORP. 510(k) NO: K072747(ABBREVIATED)
ATTN: CLAUDE L WRIGHT PHONE NO : 205-752-3774
507 SHALLOW CREEK ROAD SE DECISION MADE: 15-NOV-07
TUSCALOOSA, AL 35406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICRYL QUICK
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K072644(TRADITIONAL)
ATTN: R. RAGHUNATHAN PHONE NO : 966 1 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 07-NOV-07
P.O. BOX 51871 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNIGLACTIN
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K072645(TRADITIONAL)
ATTN: R RAGHUNATHAN PHONE NO : 966 1 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 07-NOV-07
P.O. BOX 51871 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNICAPRONE
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K072646(TRADITIONAL)
ATTN: R RAGHUNATHAN PHONE NO : 966 1 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 07-NOV-07
P.O. BOX 51871 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: COLPO-MASTER
UNITED PRODUCTS & INSTRUMENTS, INC510(k) NO: K073053(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-737-1703
377 ROUTE 17 S SE DECISION MADE: 15-NOV-07
HASBROUCK, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K071406(TRADITIONAL)
ATTN: JENNIFER BRENNAN PHONE NO : 203-492-5346
150 GLOVER AVE. SE DECISION MADE: 21-NOV-07
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
USCI IRELAND 510(k) NO: K072156(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 09-NOV-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K071760(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 09-NOV-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY SYSTEM WITH RAPIDARC
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K072916(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY M/S E-110 SE DECISION MADE: 09-NOV-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERSTITIAL NEEDLES
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K073133(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 16-NOV-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWIN-PASS OTW CATHETER, MODEL 5201
VASCULAR SOLUTIONS, INC. 510(k) NO: K072618(TRADITIONAL)
ATTN: ALYSSA MALINSKI PHONE NO : 763-646-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 21-NOV-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT
VERIDEX, LLC 510(k) NO: K071729(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-791-2438
33 TECHNOLOGY DR. SE DECISION MADE: 20-NOV-07
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
VIEWORKS CO., LTD. 510(k) NO: K073056(TRADITIONAL)
ATTN: KIM RAZA PHONE NO : 82 707 0116190
307-2, SANGDAEWON-DONG SE DECISION MADE: 13-NOV-07
JUNGWON-GU, SEONGNAM-CITY, 510(k) SUMMARY AVAILABLE FROM FDA
GYEONGGI-DO, REPUBLIC OF KOREA 462THIRD PARTY REVIEW
DEVICE: FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K071127(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 16-NOV-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITASCORE
VITASCORE B.V. 510(k) NO: K072014(TRADITIONAL)
ATTN: WIM MARTENS PHONE NO : 310 492 365290
KROMSTRAAT 3 SE DECISION MADE: 08-NOV-07
GEMERT, NETHERLANDS NL 5421 XZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
VYGON CORP. 510(k) NO: K070705(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 30-NOV-07
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
WELCH ALLYN, INC. 510(k) NO: K072449(ABBREVIATED)
ATTN: JOHN SAWYER PHONE NO : 315-685-4571
4341 STATE ST. RD. SE DECISION MADE: 29-NOV-07
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZENO ZR DISC
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K073108(SPECIAL)
ATTN: GERHARD POLZER PHONE NO : 49 072 313705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 21-NOV-07
PFORZHEIM, GERMANY 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPOD/XMAP NERVE STIMULATOR
XAVANT TECHNOLOGY (PTY), LTD. 510(k) NO: K072092(TRADITIONAL)
ATTN: ROCHE VAN RENSBURG PHONE NO : 270 123 291188
181 SOUTPANSBERG RD. SE DECISION MADE: 15-NOV-07
RIETONDALE 510(k) SUMMARY AVAILABLE FROM FDA
PRETORIA, SOUTH AFRICA 0084
DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEAD
ZIMMER, INC. 510(k) NO: K071535(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354
P.O. BOX 708 SE DECISION MADE: 19-NOV-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS
ZIMMER, INC. 510(k) NO: K072619(TRADITIONAL)
ATTN: DANIEL J WILLIMAN PHONE NO : 574-371-8065
P.O. BOX 708 SE DECISION MADE: 21-NOV-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
ZOLL MEDICAL CORPORATION 510(k) NO: K072430(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 06-NOV-07
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 240
TOTAL WITH SUMMARIES 220
TOTAL WITH STATEMENTS 20
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