FDA 510(k) Application Details - K990507

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K990507
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	ALTHIN BIOPHARM, INC. 3885 INDUSTRIAL BLVD. LAVAL, QUEBEC H7L 4S3 CA Other 510(k) Applications for this Company
Contact	JEAN SAURIOL 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	02/18/1999
Decision Date	05/07/1999
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