| Device Classification Name |
Tissue Expander And Accessories
|
| 510(k) Number |
K862049 |
| Device Name |
MENTOR FLAT-SPAN |
| Applicant |
| Mentor Corp. |
| 600 Pine Ave. |
|
Goleta,
CA
93117
|
|
| Applicant Contact |
KAREN EDWARDS |
| Correspondent |
| Mentor Corp. |
| 600 Pine Ave. |
|
Goleta,
CA
93117
|
|
| Correspondent Contact |
KAREN EDWARDS |
| Classification Product Code |
|
| Date Received | 05/29/1986 |
| Decision Date | 06/10/1986 |
| 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
|
|
|