FDA 510(k) Application Details - K965214

Device Classification Name	Gas Control Unit, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K965214
Device Name	Gas Control Unit, Cardiopulmonary Bypass
Applicant	COEUR LABORATORIES, INC. 5301 DEPATURE DR. RALEIGH, NC 27604 US Other 510(k) Applications for this Company
Contact	James M Clinton Other 510(k) Applications for this Contact
Regulation Number	870.4300   More FDA Info for this Regulation Number
Classification Product Code	DTX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1996
Decision Date	03/28/1997
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