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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)
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Decision
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factor v leiden kit ROCHE DIAGNOSTICS CORP. den030005 12/17/2003
modified trevo provue retriever, trevo xp provue retriever 4x20mm, trevo xp provue retriever 3x20mm, trevo xp provue retriever 6x25mm, trevo xp provue retriever 4x30mm CONCENTRIC MEDICAL, INC. den150049 09/02/2016
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
acucam concept iv, models a1222b, a1223b, a1221b, a1121b, a1222c, a10402, a10403, a10401 DENTSPLY INTL. k000112 04/13/2000
cortek uretheroscope CORTEK ENDOSCOPY, INC. k000200 03/03/2000
lazersmile, lazerwhite BIOLASE TECHNOLOGY, INC. k000290 04/14/2000
vision r/f tilting table VILLA SISTEMI MEDICALI S.P.A. k000412 04/24/2000
dimension garant l, dimension garant l quick ESPE DENTAL AG k000588 03/30/2000
belmont unit, model 2000 series BELMONT EQUIPMENT CORP. k000799 05/17/2000
pta balloon catheter COOK, INC. k001087 07/20/2000

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