Device Classification Name |
System, Dialysate Delivery, Central Multiple Patient
|
510(k) Number |
K861730 |
Device Name |
ACTRIL FOR KIDNEY MACHINE DISINFECTANT |
Applicant |
RENAL SYSTEMS, INC. |
14905 28TH AVE. N. |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
LEROY J FISCHBACH |
Correspondent |
RENAL SYSTEMS, INC. |
14905 28TH AVE. N. |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
LEROY J FISCHBACH |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/06/1986 |
Decision Date | 06/09/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|