FDA 510(k) Application Details - K992255

Device Classification Name	System, Dialysate Delivery, Single Patient   More FDA Info for this Device
510(K) Number	K992255
Device Name	System, Dialysate Delivery, Single Patient
Applicant	CSAM, INC. 1890 14TH ST. BETTENDORF, IA 52722 US Other 510(k) Applications for this Company
Contact	YOOBONG KIM Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/1999
Decision Date	11/30/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review