Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K951344 |
Device Name |
RMI HEMOCONCENTRATOR |
Applicant |
RESEARCH MEDICAL, INC. |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
RD HIBBERT |
Correspondent |
RESEARCH MEDICAL, INC. |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
RD HIBBERT |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/24/1995 |
Decision Date | 08/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|