Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K820304 |
Device Name |
GAMBRO GF-80-M, GF-80-H HEMODIALYZER |
Applicant |
GAMBRO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GAMBRO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/04/1982 |
Decision Date | 03/02/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|