Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K871108 |
Device Name |
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER |
Applicant |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Applicant Contact |
JEFFREY SHIDEMAN,PHD |
Correspondent |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Correspondent Contact |
JEFFREY SHIDEMAN,PHD |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/19/1987 |
Decision Date | 05/15/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|