FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS— 510(k) K991781

Name: FDA 510(k) clearance K991781
Creator: U.S. Food and Drug Administration
Published: 1999-06-29

Substantially Equivalent

G.T. Laboratories, Inc.

FDA 510(k) clearance K991781 for FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS, Substantially Equivalent on 1999-06-29. Applicant: G.T. Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: G.T. Laboratories, Inc.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 1999-05-25
Decision date: 1999-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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