FDA 510(k) Application Details - K953904

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type   More FDA Info for this Device
510(K) Number	K953904
Device Name	Pump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant	3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 ANN ARBOR, MI 48106 US Other 510(k) Applications for this Company
Contact	CHERYL ROSENBERG 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	08/18/1995
Decision Date	04/19/1996
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