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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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urotec/franklin soft simplastic catheter Urotec Systems Corp. k851684 07/02/1985
uscom 1a Uscom, Ltd. k043139 02/15/2005
vapotherm model# 2000i and 2000h Vapotherm, Inc. k070056 04/13/2007
varicella/zoster virus Institute Virion , Ltd. k843676 09/26/1985
vas-cath parallel dual luman jugular cannual cath Vas-Cath of Canada , Ltd. k844336 03/13/1985
vasopouse deep vein thrombosis compression device model ipcs, model sqs Caremed Supply, Inc. k122873 01/15/2013
ventre/sep digoxin radioimmunoassay kit Ventrex Laboratories, Inc. k791355 08/10/1979
vesseloops Sparta Surgical Corp. k905240 02/06/1991
vifs Konica Medical Corp. k955583 05/14/1996
vita cerec set and vita cerec blocs Vident k895901 01/17/1992

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