| Device Classification Name |
Disinfectant, Medical Devices
|
| 510(k) Number |
K992661 |
| Device Name |
CONTROL III ELITE |
| Applicant |
| Maril Products, Inc. |
| 320 W. 6th St. |
|
Tustin,
CA
92780
|
|
| Applicant Contact |
ANNE R WHITEHAIR |
| Correspondent |
| Maril Products, Inc. |
| 320 W. 6th St. |
|
Tustin,
CA
92780
|
|
| Correspondent Contact |
ANNE R WHITEHAIR |
| Regulation Number | 880.6890 |
| Classification Product Code |
|
| Date Received | 08/09/1999 |
| Decision Date | 09/14/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|