Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K863823 |
Device Name |
AMICON DIAFILTER HEMOFILTER |
Applicant |
AMICON, INC. |
17 CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Applicant Contact |
JAMES M DELANEY |
Correspondent |
AMICON, INC. |
17 CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
JAMES M DELANEY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/30/1986 |
Decision Date | 11/06/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|