Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K926568 |
Device Name |
BAXTER CT DIALYZER |
Applicant |
BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. |
MCGAW PK,
IL
60085
|
|
Applicant Contact |
AMY STUEBER |
Correspondent |
BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. |
MCGAW PK,
IL
60085
|
|
Correspondent Contact |
AMY STUEBER |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/31/1992 |
Decision Date | 09/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|