Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K021615 |
Device Name |
BAXTER ACCURA SYSTEM, MODEL 5M5660 |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E |
MCGAW PARK,
IL
60085 -6730
|
|
Applicant Contact |
DAVID E CURTIN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E |
MCGAW PARK,
IL
60085 -6730
|
|
Correspondent Contact |
DAVID E CURTIN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/16/2002 |
Decision Date | 11/18/2002 |
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
|
|
|