MCGEE MODIFIED STAINLESS STEEL PISTON— 510(k) K823440

Name: FDA 510(k) clearance K823440
Creator: U.S. Food and Drug Administration
Published: 1982-12-03

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K823440 for MCGEE MODIFIED STAINLESS STEEL PISTON, Substantially Equivalent on 1982-12-03. Applicant: Treace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code ETB
Device class: Class 2
Regulation: 21 CFR 874.3450
Advisory panel: Ear, Nose, Throat
Date received: 1982-11-16
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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