Device Classification Name |
system, dialysate delivery, sorbent regenerated
|
510(k) Number |
K874137 |
Device Name |
MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR |
Applicant |
ASH MEDICAL SYSTEMS, INC. |
2701 B KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
ASH, MD |
Correspondent |
ASH MEDICAL SYSTEMS, INC. |
2701 B KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
ASH, MD |
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 10/13/1987 |
Decision Date | 04/08/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|