FDA 510(k) Application Details - K001915

Device Classification Name	Marker, Cardiopulmonary Bypass (Vein Marker)   More FDA Info for this Device
510(K) Number	K001915
Device Name	Marker, Cardiopulmonary Bypass (Vein Marker)
Applicant	T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. MOORPARK, CA 93021 US Other 510(k) Applications for this Company
Contact	TIBOR KOROS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2000
Decision Date	04/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review