FDA 510(k) Application Details - K031150

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K031150
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	GLOBAL BLOOD RESOURCES, LLC 998 WINDSOR AVE. WINDSOR, CT 06095 US Other 510(k) Applications for this Company
Contact	KEITH SAMOLYK Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2003
Decision Date	06/23/2003
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