FDA 510(k) Application Details - K960974

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type   More FDA Info for this Device
510(K) Number	K960974
Device Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant	COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	MARY L ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	870.4370   More FDA Info for this Regulation Number
Classification Product Code	DWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/1996
Decision Date	07/14/1997
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