The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Ear Applicator, Catalog No. 2229.
| Device ID | K870762 |
| 510k Number | K870762 |
| Device Name: | EAR APPLICATOR, CATALOG NO. 2229 |
| Classification | Applicator, Absorbent Tipped, Non-sterile |
| Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Contact | Thomas, Jr |
| Correspondent | Thomas, Jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Product Code | KXF |
| CFR Regulation Number | 880.6025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-03-06 |