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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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zortran detector LUCENT MEDICAL SYSTEMS k000997 09/07/2000
z-net DEMITE LIMITED k001003 12/10/2001
xtd thrombectomy catheter, xx cm, model# ct000500x; xtd control console, model # ct0006001; xtd collection bottle, model XTRAK MEDICAL INC. k013473 03/06/2002
xive dental implant system FRIADENT GMBH k013867 03/15/2002
wilson-cook zilver biliary stent WILSON-COOK MEDICAL, INC. k020788 05/08/2002
willi geller creation and lf porcelain JENSEN INDUSTRIES, INC. k002904 11/06/2000
whole pth (1-84) specific immunoradiometric irma diagnostic assay kit, model 3kg056 SCANTIBODIES LABORATORY, INC. k001411 08/21/2000
wet chamber KINETIC CONCEPTS, INC. k020781 05/06/2002
wallace oocyte retrieval set-16g, model meons1633; wallace oocyte retrieval set-17g, model meons1733 SIMS PORTEX LTD. k000628 03/13/2000
wako lipase calibrator WAKO CHEMICALS, USA, INC. k001002 05/24/2000

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