| Device Classification Name |
Electrode, Depth
|
| 510(k) Number |
K802151 |
| Device Name |
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC |
| Applicant |
| Progress Mankind Technology |
| Box 464 |
|
Hopkins,
MN
55343
|
|
| Applicant Contact |
Alfred A Iversen |
| Correspondent |
| Progress Mankind Technology |
| Box 464 |
|
Hopkins,
MN
55343
|
|
| Correspondent Contact |
Alfred A Iversen |
| Regulation Number | 882.1330 |
| Classification Product Code |
|
| Date Received | 09/08/1980 |
| Decision Date | 11/19/1980 |
| 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
|
|
|