FDA 510(k) Application Details - K053021

Device Classification Name	Sucker, Cardiotomy Return, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K053021
Device Name	Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Applicant	ESTECH, INC. 1193 SHERMAN STREET ALAMEDA, CA 94501 US Other 510(k) Applications for this Company
Contact	CRAIG COOMBS Other 510(k) Applications for this Contact
Regulation Number	870.4420   More FDA Info for this Regulation Number
Classification Product Code	DTS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2005
Decision Date	01/26/2006
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