FDA 510(k) Application Details - K984322

Device Classification Name	Defoamer, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K984322
Device Name	Defoamer, Cardiopulmonary Bypass
Applicant	DIDECO S.P.A. 1601 TRAPELO RD. WALTHAM, MA 02154 US Other 510(k) Applications for this Company
Contact	BARRY SALL 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	12/03/1998
Decision Date	03/02/1999
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