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510(k) Data Aggregation

    K Number
    K990011
    Device Name
    CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    CONTINENTAL SOFT LENS, INC.
    Date Cleared
    1999-05-11

    (127 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTINENTAL SOFT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
    Device Description
    Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens
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