FDA 510(k) Application Details - K014016

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K014016
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	MINNTECH CORP. 14605 28TH AVE. NORTH MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	LYNN LUCDERS Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2001
Decision Date	02/01/2002
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