| Device Classification Name |
Stimulator, Nerve
|
| 510(k) Number |
K872791 |
| Device Name |
POREX NERVE LOCATOR |
| Applicant |
| Porex Medical |
| 500 Bohannon Rd. |
|
Fairburn,
GA
30213
|
|
| Applicant Contact |
MERCER, PHD |
| Correspondent |
| Porex Medical |
| 500 Bohannon Rd. |
|
Fairburn,
GA
30213
|
|
| Correspondent Contact |
MERCER, PHD |
| Regulation Number | 874.1820 |
| Classification Product Code |
|
| Date Received | 07/14/1987 |
| Decision Date | 10/20/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|