FDA 510(k) Application Details - K980659

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K980659
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	ADVANCED RENAL TECHNOLOGIES, INC. 2151 NORTH NORTHLAKE WAY, #200 SEATTLE, WA 98103 US Other 510(k) Applications for this Company
Contact	ROBIN CALLAN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/1998
Decision Date	06/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review