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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
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vesseloops Sparta Surgical Corp. k905240 02/06/1991
ghajar intraventricular catheter guide Sparta Instrument Corp. k854475 02/20/1986
local report generator Spacelabs, Inc. k904318 12/18/1990
esophageal stethoscope temperature probe Spacelabs, Inc. k912742 04/20/1992
spec model m-31 Source Production & Equipment Co., Inc. k090366 04/22/2009
bcd advanced blood carioplegia systems Sorin Biomedica, Fiat, USA, Inc. k925369 03/26/1993
cranex novus Soredex Palodex Group OY k063459 12/26/2006
x-view Sometech Corporation k024186 04/01/2004
solarcare alanine aminotransferase micro-plate assay Solarcare, Inc. k941497 05/24/1994
histofreezer Solarcare Technologies Corp,Inc. k931299 08/11/1993

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