FDA 510(k) Application Details - K992592

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K992592
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	A-MED SYSTEMS, INC. 2491 BOATMAN AVE. WEST SACRAMENTO, CA 95691 US Other 510(k) Applications for this Company
Contact	ROBERTA THOMPSON Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/1999
Decision Date	05/04/2000
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