FDA 510(k) Application Details - K090690

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K090690
Device Name	Reservoir, Blood, 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	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2009
Decision Date	12/23/2009
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