The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Mirror Tip.
| Device ID | K823915 |
| 510k Number | K823915 |
| Device Name: | MIRROR TIP |
| Classification | Mirror, Ent |
| Applicant | TREACE MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KAI |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-01-21 |