Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K992573 |
Device Name |
AF-220 HEMODIALYZER |
Applicant |
ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 |
RONNEBY,
SE
S-37221
|
|
Applicant Contact |
LARS-OLOF SANDBERB |
Correspondent |
ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 |
RONNEBY,
SE
S-37221
|
|
Correspondent Contact |
LARS-OLOF SANDBERB |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/02/1999 |
Decision Date | 01/18/2000 |
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
|
|
|