Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K844663 |
Device Name |
ASAHI NEW PAN-SERIES HEMOFILTERS |
Applicant |
ASAHI MEDICAL CO., LTD. |
C/O ADVOCACY SERVICES GROUP |
1825 I STREET, N.W., SUITE 400 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
RICHARD T NEY |
Correspondent |
ASAHI MEDICAL CO., LTD. |
C/O ADVOCACY SERVICES GROUP |
1825 I STREET, N.W., SUITE 400 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
RICHARD T NEY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 11/30/1984 |
Decision Date | 01/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|