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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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elecsys b-crosslaps calcheck ROCHE DIAGNOSTICS CORP. k000042 03/17/2000
drg aurica elisa testosterone kit DRG INTL., INC. k000043 04/17/2000
arthrocare controller, arthrocare cable, footswitch, powercord, arthrowands and spinewands ARTHROCARE CORP. k000044 02/01/2000
positube PARAPRODUCTS, INC. k000045 03/15/2000
knight endoscopic spine system (kess) RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000046 03/30/2000
nupro prophylaxis paste with fluoride and triclosan DENTSPLY INTL. k000169 03/24/2000
secca tubular electrode device, model a4000 CONWAY STUART MEDICAL, INC. k000170 02/14/2000
cbyon surgical operating system (sos) CBYON, INC. k000171 03/13/2000
depuy contour unicompartmental knee prosthesis DEPUY ORTHOPAEDICS, INC. k000172 02/03/2000
cement it! universal c&b JENERIC/PENTRON, INC. k000173 02/29/2000

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