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    K Number
    K992446
    Device Name
    DAILIES (NELFILCON A) ONE-DAY
    Manufacturer
    CIBA VISION JOHNS CREEK MFG.
    Date Cleared
    1999-08-18

    (27 days)

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

    CIBA VISION JOHNS CREEK MFG.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes. DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES® lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution.
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