FDA 510(k) Application Details - K013915

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K013915
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	DIDECO S.P.A. 14401 WEST 65TH WAY ARVADA, CO 80004-3599 US Other 510(k) Applications for this Company
Contact	SHAWN RIEDEL 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	11/27/2001
Decision Date	12/27/2001
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