Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K963440 |
Device Name |
DIALOG DIALYSIS MACHINE |
Applicant |
B. BRAUN MEDICAL AG |
824 12TH AVE. |
P.O. BOX 4027 |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL AG |
824 12TH AVE. |
P.O. BOX 4027 |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/30/1996 |
Decision Date | 06/26/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|