FDA 510(k) Application Details - K003145

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K003145
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	ORIGEN BIOMEDICAL, INC. 2525 HARTFORD RD. AUSTIN, TX 78703-2428 US Other 510(k) Applications for this Company
Contact	RICHARD MARTIN Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2000
Decision Date	04/20/2001
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