FDA 510(k) Application Details - K112225

Device Classification Name	Control, Pump Speed, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K112225
Device Name	Control, Pump Speed, Cardiopulmonary Bypass
Applicant	SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON Other 510(k) Applications for this Contact
Regulation Number	870.4380   More FDA Info for this Regulation Number
Classification Product Code	DWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2011
Decision Date	09/20/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review