Device Classification Name |
subsystem, water purification
|
510(k) Number |
K061782 |
Device Name |
GAMBRO POSICLEAR |
Applicant |
GAMBRO SERVICES, INC. |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Applicant Contact |
JEFFERY R SHIDEMAN |
Correspondent |
GAMBRO SERVICES, INC. |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Correspondent Contact |
JEFFERY R SHIDEMAN |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 06/26/2006 |
Decision Date | 01/04/2007 |
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
|
|
|