FDA 510(k) Application Details - K972321

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type   More FDA Info for this Device
510(K) Number	K972321
Device Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant	STOECKERT INSTRUMENTE 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON Other 510(k) Applications for this Contact
Regulation Number	870.4370   More FDA Info for this Regulation Number
Classification Product Code	DWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/1997
Decision Date	02/27/1998
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