FDA 510(k) Application Details - K020365

Device Classification Name	Accessory Equipment, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K020365
Device Name	Accessory Equipment, Cardiopulmonary Bypass
Applicant	3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. CONIFER, CO 80433-6204 US Other 510(k) Applications for this Company
Contact	ROBERT P EATON Other 510(k) Applications for this Contact
Regulation Number	870.4200   More FDA Info for this Regulation Number
Classification Product Code	KRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2002
Decision Date	05/03/2002
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