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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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scintillant dual bent tip surgical light, scintillant dual straight tip surgical light Engineered Medical Solutions Co., LLC k133425 12/05/2013
mod. endoport single-use trocar and sleeve Endotherapeutics k860103 02/12/1986
cathscanner(r) pta balloon dilatation catheter Endosonics Corp. k902454 08/30/1990
latex patient examination gloves Encore Products, Inc. k892573 07/14/1989
modified island pin tens disposable electrode Empi k901102 03/23/1990
easy-test emit procainamide (proc) #16648 Em Diagnostic Systems, Inc. k873350 09/29/1987
synelisa ana total Elias U.S.A., Inc. k935468 03/25/1994
ebice Electro-Biology, Inc. k945067 02/09/1995
flo trac sensor, volume view sensor Edwards Lifesciences, LLC k152980 01/19/2016
cardiovascular instruments-various Edward Weck, Inc. k791710 09/12/1979

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