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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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dynamometer - model fce and model msc AMETEK k042889 11/16/2004
spor-test pa biological indicator kit GETINGE USA, INC k050664 04/07/2005
enpath deflectable catheter ENPATH MEDICAL INCORPORATED k043489 05/19/2005
potassium test kit and electrolyte cal 1 and 2 RANDOX LABORATORIES, LTD. k043267 02/10/2005
lysus infusion system EKOS CORP. k050472 03/11/2005
ventana image analysis system TRIPATH IMAGING, INC. k050012 05/06/2005
veinnovations infiltration system VEINNOVATIONS, LLC k050474 04/14/2005
bioblanket surgical mesh KENSEY NASH CORP. k043259 08/15/2005
lysus infusion system EKOS CORP. k043269 12/22/2004
midas touch latex examination gloves-powdered INDUSTRIAL CLOTHINGS, LTD. k000141 09/13/2000

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