FDA 510(k) Application Details - K081838

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K081838
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	GISH BIOMEDICAL, INC. 22942 ARROYO VISTA RANCHO SANTA MARGARITA, CA 92688 US Other 510(k) Applications for this Company
Contact	MARTIN SELLERS 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	06/30/2008
Decision Date	01/26/2009
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