FLOSI RIGID GAS PERMEABLE CONTACT LENS— 510(k) K974636

Name: FDA 510(k) clearance K974636
Creator: U.S. Food and Drug Administration
Published: 1998-03-30

Substantially Equivalent

Futuristic Design Assoc.

FDA 510(k) clearance K974636 for FLOSI RIGID GAS PERMEABLE CONTACT LENS, Substantially Equivalent on 1998-03-30. Applicant: Futuristic Design Assoc.. Device class: 2.

Clearance details

Applicant: Futuristic Design Assoc.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 1997-12-12
Decision date: 1998-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, OH, 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.