Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K962309 |
Device Name |
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS |
Applicant |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Applicant Contact |
MARY LANE |
Correspondent |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Correspondent Contact |
MARY LANE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/17/1996 |
Decision Date | 12/27/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|