AUSTIN ENDOLYMPH DISPERSMENT SHUNT— 510(k) K834094

Name: FDA 510(k) clearance K834094
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K834094 for AUSTIN ENDOLYMPH DISPERSMENT SHUNT, Substantially Equivalent on 1984-09-20. Applicant: Treace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code ESZ
Device class: Class 2
Regulation: 21 CFR 874.3820
Advisory panel: Ear, Nose, Throat
Date received: 1983-11-28
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K897049 — GIBSON ENDOLYMPHATIC SHUNT1990-03-16

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