FDA 510(k) Application Details - K103762

Device Classification Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K103762
Device Name	Console, Heart-Lung Machine, 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, RN, MED, RAC Other 510(k) Applications for this Contact
Regulation Number	870.4220   More FDA Info for this Regulation Number
Classification Product Code	DTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2010
Decision Date	01/20/2011
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