FDA 510(k) Application Details - K992599

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K992599
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	DIDECO S.P.A. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA J.M. NOLTE 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	08/03/1999
Decision Date	11/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review