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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)
Number
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Decision
Date
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spi vario angled abutment THOMMEN MEDICAL, AG k111984 11/10/2011
version of a closed-flow sys. caloric THOMAS M. FOTI, M.D. k813490 01/07/1982
uv glucose determ., auto chem. analyzers THE DOW CHEMICAL CO. k771102 11/22/1977
boston blood donor sets THE BOSTON MEDICAL GROUP k822410 09/30/1982
glidesheath TERUMO MEDICAL CORP. k102008 07/21/2010
terumo capiox sx18 oxygenator/ hardshell reservoir, terumo capiox sx18 oxygenator/ hardshell reservoir with xcoating, terumo capiox sx25 oxygenator/hardshell reservoir, terumo capiox sx25 oxygenator/hardshell reservoir with xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP. k153140 12/02/2015
emit-tox serum benzodiazepine assay SYVA CO. k790736 04/26/1979
emit auto digoxin assay SYVA CO. k790937 06/15/1979
analyzer, model cc-720 SYSMEX CORP. k790026 02/08/1979
synthes (usa) 3.5mm lcp hook plate SYNTHES (USA) k082072 11/07/2008

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