| Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
| 510(k) Number |
K904258 |
| Device Name |
MICRO DERM |
| Applicant |
| Monad Corp. |
| 908 E. Holt Ave. |
|
Pomona,
CA
91767
|
|
| Applicant Contact |
MARK HANKINS |
| Correspondent |
| Monad Corp. |
| 908 E. Holt Ave. |
|
Pomona,
CA
91767
|
|
| Correspondent Contact |
MARK HANKINS |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 09/14/1990 |
| Decision Date | 05/13/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|