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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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510(K)
Number
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Decision
Date
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the bioplate bioclip craniotomy fixation system BIOPLATE, INC. k001530 07/21/2000
dyna-lok classic spinal system MEDTRONIC SOFAMOR DANEK, INC. k001532 06/16/2000
surgiflator-40 W.O.M. GMHB k001533 07/31/2000
pinnacle acetabular system DEPUY ORTHOPAEDICS, INC. k001534 06/12/2000
zenith plate system, anterior spinal instrumentation ORTHOTEC, L.L.C. k001535 03/20/2001
inter-op metasul hooded and protrusio acetabular inserts SULZER ORTHOPEDICS, INC. k001536 07/27/2000
renu multiplus multi-purpose solution BAUSCH & LOMB, INC. k001539 07/31/2000
minicam VIDEO DENTAL CONCEPTS, INC. k001541 07/21/2000
bpc-3000 personal blood pressure communicator, model 52520 WELCH ALLYN, INC. k001543 01/29/2001
vaginal applicator shielded MICK RADIO-NUCLEAR INSTRUMENTS, INC. k001544 11/17/2000

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