FENESTRA HOOK— 510(k) K841359

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K841359 for FENESTRA HOOK, Substantially Equivalent on 1984-07-18. Applicant: Treace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code IYL
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 1984-04-02
Decision date: 1984-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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