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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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microstrep plus panel amoxicillin/clavulanic acid Dade Behring, Inc. k062596 09/19/2006
dimension vista (tm) bhcg flex(r) reagent cartridge, and bhcg calibrator, model# k6430,kc632 Dade Behring, Inc. k063754 02/23/2007
dimension vista system igg flex reagent cartridge, dimension vista system protein 1 calibrator, and dimension vista syst Dade Behring, Inc. k081161 07/28/2008
dacomed corp. eska-herrman voice prosthesis Dacomed Corp. k854118 03/17/1986
surgiclear antimicrobial clear silicone adhesive dressing with chlorhexidine and silver Covalontechnologies, Inc. k121819 08/13/2012
cosmedtech cannula Cosmedtech, Inc. k870560 03/04/1987
corning 2500 co-oximeter Corning Medical & Scientific k830590 04/05/1983
cordis angiographic doppler cather Cordis Corp. k915498 04/17/1992
duoderm hydrocolloid gel Convatec, A Division of E.R. Squibb & Sons k931618 12/10/1993
graspers & scissors (minimal access surg instr) Conmedcorp k924469 04/07/1993

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