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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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unifil flow GC AMERICA, INC. k020342 03/28/2002
surgassist system; wireless remote control (component); wired remote control POWER MEDICAL INTERVENTIONS, INC. k020343 04/10/2002
rpx titanium cemnt restrictor SULZER SPINE-TECH k020344 05/02/2002
arthrex univers fracture prosthesis ARTHREX, INC. k020345 09/06/2002
agc speziallegierung WIELAND EDELMETALLE GMBH & CO. k020347 04/24/2002
abbott axsym anti-thyroid-peroxidase, models5f57 comprising standards/calibrators AXIS-SHIELD DIAGNOSTICS, LTD. k020348 05/02/2002
abbott axsym anti-thyroglobulin, models 5f5b comprising standard/calibrators AXIS-SHIELD DIAGNOSTICS, LTD. k020349 05/02/2002
bci 3180 pulse oximeter BCI, INC. k020350 04/30/2002
d 903 avant 2 ph.i.s.i.o. adult hollow fiber oxygenator DIDECO S.P.A. k020351 02/26/2002
surgical dynamics ogden suture anchor with suture UNITED STATES SURGICAL k020352 02/26/2002

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