Device Classification Name |
System, Dialysate Delivery, Sorbent Regenerated
|
510(k) Number |
K864179 |
Device Name |
BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR |
Applicant |
ASH MEDICAL SYSTEMS, INC. |
2701 B KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
STEPHEN R ASH |
Correspondent |
ASH MEDICAL SYSTEMS, INC. |
2701 B KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
STEPHEN R ASH |
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 10/24/1986 |
Decision Date | 12/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|