Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K913950 |
Device Name |
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY |
Applicant |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Applicant Contact |
MARIAN D HARDING |
Correspondent |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Correspondent Contact |
MARIAN D HARDING |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/04/1991 |
Decision Date | 11/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|