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FDA 510(k) Application Details - K964907
Device Classification Name
Reservoir, Blood, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K964907
Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Applicant
SORIN BIOMEDICAL, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE, CA 92713-9503 US
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Contact
RICHARD J DERISIO
Other 510(k) Applications for this Contact
Regulation Number
870.4400
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Classification Product Code
DTN
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More FDA Info for this Product Code
Date Received
12/09/1996
Decision Date
08/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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