Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K855251 |
Device Name |
MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS |
Applicant |
ADVOCACY INTERNATIONAL, LTD. |
INTERNATIONA SQUARE |
1825 EYE STREET N.W. SUITE 400 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
RICHARD T NEY |
Correspondent |
ADVOCACY INTERNATIONAL, LTD. |
INTERNATIONA SQUARE |
1825 EYE STREET N.W. SUITE 400 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
RICHARD T NEY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/30/1985 |
Decision Date | 02/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|