| 510(k) Number |
K862582 |
| Device Name |
TREACE MEDICAL MICRO INSTRUMENT WIPE |
| Applicant |
| Treace Medical, Inc. |
| Suite 400 |
| 22 N. Second St. |
|
Memphis,
TN
38103
|
|
| Applicant Contact |
WILLIAM H THOMAS,JR |
| Correspondent |
| Treace Medical, Inc. |
| Suite 400 |
| 22 N. Second St. |
|
Memphis,
TN
38103
|
|
| Correspondent Contact |
WILLIAM H THOMAS,JR |
| Date Received | 07/07/1986 |
| Decision Date | 07/30/1986 |
| 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
|
|
|