FDA 510(k) Application Details - K082412

Device Classification Name	Defoamer, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K082412
Device Name	Defoamer, Cardiopulmonary Bypass
Applicant	MAPQUET 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	870.4230   More FDA Info for this Regulation Number
Classification Product Code	DTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2008
Decision Date	11/10/2008
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