FDA 510(k) Application Details - K043207

Device Classification Name	Disinfectant, Dialysate Delivery System   More FDA Info for this Device
510(K) Number	K043207
Device Name	Disinfectant, Dialysate Delivery System
Applicant	GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES 5951 CLEARWATER DRIVE MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	CHARLENE NASH Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	NII Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2004
Decision Date	11/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review