| Device Classification Name |
Dialyzer Reprocessing System
|
| 510(k) Number |
K832705 |
| Device Name |
ULTRAMAX |
| Applicant |
| Medicorp, Inc. |
| 240 W. 2950 South |
|
Salt Lake City ,
UT
84115
|
|
| Applicant Contact |
RICHARD K FIFE |
| Correspondent |
| Medicorp, Inc. |
| 240 W. 2950 South |
|
Salt Lake City ,
UT
84115
|
|
| Correspondent Contact |
RICHARD K FIFE |
| Regulation Number | 876.5820 |
| Classification Product Code |
|
| Date Received | 08/12/1983 |
| Decision Date | 06/25/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|