Device Classification Name |
Tank, Holding, Dialysis
|
510(k) Number |
K051031 |
Device Name |
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS |
Applicant |
AMERIWATER |
1257 STANLEY AVE. |
DAYTON,
OH
45404
|
|
Applicant Contact |
BRIAN R BOWMAN |
Correspondent |
AMERIWATER |
1257 STANLEY AVE. |
DAYTON,
OH
45404
|
|
Correspondent Contact |
BRIAN R BOWMAN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/22/2005 |
Decision Date | 01/06/2006 |
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
|
|
|