AUSTIN MODIFIED TOTAL OSSICULAR REPLACE— 510(k) K823912

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K823912 for AUSTIN MODIFIED TOTAL OSSICULAR REPLACE, Substantially Equivalent on 1983-06-24. Applicant: Treace Medical, Inc..

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code ETA
Advisory panel: Ear, Nose, Throat
Date received: 1982-12-28
Decision date: 1983-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.