K822373 is an FDA 510(k) clearance for the EAR SURGERY SPECULUM. This device is classified as a Speculum, Ent (Class I - General Controls, product code EPY).
Submitted by Treace Medical, Inc. (Walker, US). The FDA issued a Cleared decision on September 9, 1982, 34 days after receiving the submission on August 6, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.1800.
| 510(k) Number | K822373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1982 |
| Decision Date | September 09, 1982 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EPY — Speculum, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.1800 |