Device Classification Name |
subsystem, water purification
|
510(k) Number |
K994279 |
Device Name |
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) |
Applicant |
PURE WATER SOLUTIONS, INC. |
14550 EAST EASTER AVE., #800 |
ENGLEWOOD,
CO
80112 -4271
|
|
Applicant Contact |
DEAN S LEWIS |
Correspondent |
PURE WATER SOLUTIONS, INC. |
14550 EAST EASTER AVE., #800 |
ENGLEWOOD,
CO
80112 -4271
|
|
Correspondent Contact |
DEAN S LEWIS |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 12/20/1999 |
Decision Date | 12/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|