Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K963203 |
Device Name |
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT |
Applicant |
BAXTER HEALTHCARE CORP. |
17221 RED HILL AVE. |
P.O. 11150 |
SANTA ANA,
CA
92711 -1150
|
|
Applicant Contact |
SCOTT BEGGINS |
Correspondent |
BAXTER HEALTHCARE CORP. |
17221 RED HILL AVE. |
P.O. 11150 |
SANTA ANA,
CA
92711 -1150
|
|
Correspondent Contact |
SCOTT BEGGINS |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/15/1996 |
Decision Date | 03/25/1997 |
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
|