C-FLEX ENDOLYMPHATIC SHUNT— 510(k) K952227

Name: FDA 510(k) clearance K952227
Creator: U.S. Food and Drug Administration
Published: 1995-06-16

Substantially Equivalent

Trebay Medical Corp.

FDA 510(k) clearance K952227 for C-FLEX ENDOLYMPHATIC SHUNT, Substantially Equivalent on 1995-06-16. Applicant: Trebay Medical Corp.. Device class: 2.

Clearance details

Applicant: Trebay Medical Corp.
Product code: Code ESZ
Device class: Class 2
Regulation: 21 CFR 874.3820
Advisory panel: Ear, Nose, Throat
Date received: 1995-05-12
Decision date: 1995-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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