FDA 510(k) Application Details - K013038

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K013038
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	POLYSTAN A/S WALGERHOLM 8 VAERLOSE DK-3500 DK Other 510(k) Applications for this Company
Contact	DANA OLSEN 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	09/10/2001
Decision Date	08/14/2002
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