| 510(k) Number |
K861914 |
| Device Name |
TREACE MEDICAL FOAM INSTRUMENT PAD |
| Applicant |
| Treace Medical, Inc. |
| Suite 400 |
| 22 N. Second St. |
|
Memphis,
TN
38103
|
|
| Applicant Contact |
THOMAS JR |
| Correspondent |
| Treace Medical, Inc. |
| Suite 400 |
| 22 N. Second St. |
|
Memphis,
TN
38103
|
|
| Correspondent Contact |
THOMAS JR |
| Date Received | 05/19/1986 |
| Decision Date | 06/06/1986 |
| 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
|
|
|