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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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sonoace 600 diagnostic ultrasound system MEDISON AMERICA, INC. k000030 01/19/2000
arthrocare controller, arthrocare cable, footswitch, powercord, arthrowands and spinewands ARTHROCARE CORP. k000044 02/01/2000
modification to isobar spinal system ENCORE ORTHOPEDICS, INC. k000020 02/03/2000
depuy contour unicompartmental knee prosthesis DEPUY ORTHOPAEDICS, INC. k000172 02/03/2000
entec reflex wand 55, model e4055-00 ARTHROCARE CORP. k000036 02/04/2000
datex-ohmeda inovent delivery system DATEX-OHMEDA k000186 02/10/2000
synchron lx systems microalbumin calibrator BECKMAN COULTER, INC. k000331 02/10/2000
audioscreener oae KEDLY, INC. k000184 02/11/2000
secca tubular electrode device, model a4000 CONWAY STUART MEDICAL, INC. k000170 02/14/2000
gore-tex dualmesh plus biomaterial (1 mm & 2mm) W.L. GORE & ASSOCIATES,INC k000185 02/14/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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