WATER PURIFICATION SYSTEM FOR HEMODIALYSIS


the company

Device Classification Name

subsystem, water purification

510(k) Number K002045
Device Name WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Original Applicant
TOTAL WATER TREATMENT SYSTEMS, INC.
4806 east broadway
madison, 
WI 
53716

Original Contact kenneth j clark
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 07/05/2000
Decision Date 02/16/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No