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    K Number
    K974636
    Device Name
    FLOSI RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    FUTURISTIC DESIGN ASSOC.
    Date Cleared
    1998-03-30

    (108 days)

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

    FUTURISTIC DESIGN ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell.
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