Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K082400 |
Device Name |
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS |
Applicant |
CULLIGAN SOFT WATER SERVICE CO. |
6030 CULLIGAN WAY |
MINNETONKA,
MN
55345
|
|
Applicant Contact |
MIKE JABLONSKI |
Correspondent |
CULLIGAN SOFT WATER SERVICE CO. |
6030 CULLIGAN WAY |
MINNETONKA,
MN
55345
|
|
Correspondent Contact |
MIKE JABLONSKI |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 08/20/2008 |
Decision Date | 02/03/2009 |
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
|
|
|