Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K030974 |
FOIA Releasable 510(k) |
K030974
|
Device Name |
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
DAVID E CURTIN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
DAVID E CURTIN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/28/2003 |
Decision Date | 04/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|