Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K010985 |
Device Name |
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
Applicant |
GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 04/02/2001 |
Decision Date | 10/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|