TOTAL OSSICULAR REPLACEMENT— 510(k) K823919
Substantially EquivalentTreace Medical, Inc.
FDA 510(k) clearance K823919 for TOTAL OSSICULAR REPLACEMENT, Substantially Equivalent on 1983-06-24. Applicant: Treace Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Treace Medical, Inc.
- Product code
- Code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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