Device Classification Name |
subsystem, water purification
|
510(k) Number |
K002045 |
Device Name |
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
Applicant |
TOTAL WATER TREATMENT SYSTEMS, INC. |
4806 EAST BROADWAY |
MADISON,
WI
53716
|
|
Applicant Contact |
KENNETH J CLARK |
Correspondent |
TOTAL WATER TREATMENT SYSTEMS, INC. |
4806 EAST BROADWAY |
MADISON,
WI
53716
|
|
Correspondent Contact |
KENNETH J CLARK |
Regulation Number | 876.5665
|
Classification Product Code |
|
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
|
|
|