FDA 510(k) Application Details - K112360

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K112360
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 HIRRLINGEN 72145 DE Other 510(k) Applications for this Company
Contact	KATRIN SCHWENKGLENKS Other 510(k) Applications for this Contact
Regulation Number	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2011
Decision Date	09/15/2011
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