FDA 510(k) Application Details - K090449

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K090449
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	GISH BIOMEDICAL, INC. 22942 ARROYO VISTA RANCHO SANTA MARGARITA, CA 92688 US Other 510(k) Applications for this Company
Contact	JANET PEETS Other 510(k) Applications for this Contact
Regulation Number	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2009
Decision Date	09/18/2009
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