EZYPOR— 510(k) K212741

Name: FDA 510(k) clearance K212741
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Substantially Equivalent

Fci (France Chirurgie Instrumentation) Sas

FDA 510(k) clearance K212741 for EZYPOR, Substantially Equivalent on 2022-06-24. Applicant: Fci (France Chirurgie Instrumentation) Sas. Device class: 2.

Clearance details

Applicant: Fci (France Chirurgie Instrumentation) Sas
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2021-08-30
Decision date: 2022-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II2009-03-12
K082850 — EYE SPHERES2009-02-27

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