MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS— 510(k) K103561

Name: FDA 510(k) clearance K103561
Creator: U.S. Food and Drug Administration
Published: 2011-02-03

Substantially Equivalent

Menicon Co, Ltd.

FDA 510(k) clearance K103561 for MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS, Substantially Equivalent on 2011-02-03. Applicant: Menicon Co, Ltd.. Device class: 2.

Clearance details

Applicant: Menicon Co, Ltd.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2010-12-06
Decision date: 2011-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, 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.