Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K854309 |
Device Name |
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 |
Applicant |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Applicant Contact |
JEFFREY SHIDEMAN |
Correspondent |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Correspondent Contact |
JEFFREY SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 10/25/1985 |
Decision Date | 12/13/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|