| 510(k) Number |
K870059 |
| Device Name |
MENTOR NIPPLE RECONSTRUCTION DEVICE |
| Applicant |
| Mentor Corp. |
| 600 Pine Ave. |
|
Goleta,
CA
93117
|
|
| Applicant Contact |
LYNN BRECKENRIDGE |
| Correspondent |
| Mentor Corp. |
| 600 Pine Ave. |
|
Goleta,
CA
93117
|
|
| Correspondent Contact |
LYNN BRECKENRIDGE |
| Date Received | 01/07/1987 |
| Decision Date | 02/24/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|