Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K892375 |
Device Name |
MODIFIED AM-SERIES DIALYZERS |
Applicant |
ASAHI MEDICAL CO., LTD. |
INTL. SQUARE |
1825 EYE ST., N.W., SUITE 400 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
RICHARD T NEY |
Correspondent |
ASAHI MEDICAL CO., LTD. |
INTL. SQUARE |
1825 EYE ST., N.W., SUITE 400 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
RICHARD T NEY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/31/1989 |
Decision Date | 05/18/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|