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510(k) Data Aggregation

    K Number
    K990895
    Device Name
    OXYCON LENS
    Manufacturer
    CONCISE CONTACT LENS CO.
    Date Cleared
    1999-04-14

    (28 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCISE CONTACT LENS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oxycon (wilofocon A) Rigid Gas Permeable, Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and nonaphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    The Oxycon (wilofocon A) Rigid Gas Permeable Contact Lens is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, wilofocon A, is a fluoro silicone acrylate polymer which contains D&C Green No. 6 as a color additive. The Oxycon (wilofocon A) Contact Lens is a hemispherical shell.
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