FDA 510(k) Application Details - K964908

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K964908
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 IRVINE, CA 92713-9503 US Other 510(k) Applications for this Company
Contact	RICHARD J DERISIO Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/1996
Decision Date	09/03/1997
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