AQUA WATER TREATMENT FOR HEMODIALYSIS


Device Classification Name

subsystem, water purification

510(k) Number K010592
Device Name AQUA WATER TREATMENT FOR HEMODIALYSIS
Original Applicant
AQUA WATER TREATMENT, INC.
8195 east bay blvd.
navarre, 
FL 
32566

Original Contact anthony weathers
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 02/28/2001
Decision Date 09/28/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No