FDA 510(k) Application Details - K990512

Device Classification Name	Accessory Equipment, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K990512
Device Name	Accessory Equipment, Cardiopulmonary Bypass
Applicant	STOECKERT INSTRUMENTE 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA JM NOLTE Other 510(k) Applications for this Contact
Regulation Number	870.4200   More FDA Info for this Regulation Number
Classification Product Code	KRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/1999
Decision Date	11/23/1999
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