DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS


Device Classification Name

subsystem, water purification

510(k) Number K021352
Device Name DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
Original Applicant
DAYTON WATER SYSTEMS
430 leo st.
dayton, 
OH 
45404

Original Contact dayne gilleland
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 04/29/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No