FDA 510(k) Application Details - K101046

Device Classification Name	Gas Control Unit, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K101046
Device Name	Gas Control Unit, 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	870.4300   More FDA Info for this Regulation Number
Classification Product Code	DTX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2010
Decision Date	12/09/2010
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