Device Classification Name |
Tank, Holding, Dialysis
|
510(k) Number |
K993058 |
Device Name |
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL |
Applicant |
PURE WATER, INC. |
305 WEST MARKET ST. |
ANDERSON,
SC
29624
|
|
Applicant Contact |
RHONDA S MCCOY |
Correspondent |
PURE WATER, INC. |
305 WEST MARKET ST. |
ANDERSON,
SC
29624
|
|
Correspondent Contact |
RHONDA S MCCOY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/13/1999 |
Decision Date | 01/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|