FDA 510(k) Application Details - K964571

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K964571
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	LIFESTREAM INT'L, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON, R.N., RAC Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/1996
Decision Date	08/08/1997
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