FDA 510(k) Applications for Medical Device:
Light, Surgical, Fiberoptic

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K093386 BFW, INC 2307 RIVER ROAD
LOUISVILLE KY 40206
K051786 DESIGNS FOR VISION, INC. 49 PLAIN STREET
NORTH ATTLEBORO MA 02760
K141330 ENROXTECH, INC. 4655 KIRKWOOD COURT
BOULDER CO 80301
K061690 GULF MEDICAL FIBEROPTICS 148 DUNBAR AVE., UNIT B
OLDSMAR FL 34677
K200874 Innovasis, Inc. 614 East 3900 South
Salt Lake City UT 84107
K113697 INVUITY, INC. 39 STILLMAN STREET
SAN FRANCISO CA 94107
K090070 INVUITY, INC. 155-A MOFFETT PARK DRIVE
SUNNYVALE CA 94089
K991572 ISOLUX AMERICA 1479 RAILHEAD BLVD.
NAPLES FL 34110-8444
K102266 ISOLUX LLC 1045 COLLIER CENTER WAY
NAPLES FL 34110-8444
K100388 MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST.
SAN FERNANDO CA 91340
K053227 MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST.
SAN FERNANDO CA 91340
K000728 MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH
JACKSONVILLE FL 32216
K042034 NUVASIVE, INC. 10065 OLD GROVE RD.
SAN DIEGO CA 92131
K955510 PRODUCTS FOR MEDICINE 3722 AVE.
IRVINE CA 92714
K113330 SENSORMED 2450 EJ CHAPMAN DR.,
KNOXVILLE TN 37996
K101496 SENSORMED 2450 EJ CHAPMAN DR., SUITE 104
KNOXVILLE TN 37996
K082992 SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100
CARLSBAD CA 92010
K100395 STERIS Corporation 5960 Heisley Road
Mentor OH 44060
K003577 STERIS Corporation 2720 GUNTER PARK EAST
MONTGOMERY AL 36109
K122637 STRYKER SPINE 2 PEARL COURT
ALLENDALE NJ 07401
K083710 THOMAS SURGICAL INSTRUMENTS, INC. 10170 E. CHERRY BEND RD.
TRAVERSE CITY MI 49684
K080962 THOMPSON SURGICAL INSTRUMENTS, INC. 10170 EAST CHERRY BEND ROAD
TRAVERSE CITY MI 49684
K972225 UNIVERSAL FIBEROPTIC REPAIR, INC. 9 WRIGHTS CROSSING
POMFRET CENTER CT 06259
K071218 WELCH ALLYN, INC. 4341 STATE STREET ROAD
SKANEATELES FALLS NY 13153-0220
K080367 ZIMMER SPINE, INC. 7375 BUSH LAKE RD.
MINNEAPOLIS MN 55439




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