Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K121409 |
Device Name |
ASAHI REXEED-SX/LX SERIES DIALYZER |
Applicant |
ASAHI KASEI MEDICAL CO., LTD. |
154 MAIN STREET, STE 2 |
CHARLESTOWN,
NH
03603
|
|
Applicant Contact |
Patsy Trisler |
Correspondent |
ASAHI KASEI MEDICAL CO., LTD. |
154 MAIN STREET, STE 2 |
CHARLESTOWN,
NH
03603
|
|
Correspondent Contact |
Patsy Trisler |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/11/2012 |
Decision Date | 02/06/2013 |
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
|
|
|