TOTAL— 510(k) K822367

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K822367 for TOTAL, Substantially Equivalent on 1982-09-07. Applicant: Treace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code LBN
Device class: Class 2
Regulation: 21 CFR 874.3495
Advisory panel: Ear, Nose, Throat
Date received: 1982-08-06
Decision date: 1982-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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