The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Ear Surgery Speculum.
| Device ID | K822373 |
| 510k Number | K822373 |
| Device Name: | EAR SURGERY SPECULUM |
| Classification | Speculum, Ent |
| Applicant | TREACE MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EPY |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-06 |
| Decision Date | 1982-09-09 |