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510(k) Data Aggregation

    K Number
    K991620
    Device Name
    VISINE FOR CONTACTS
    Manufacturer
    Date Cleared
    1999-09-24

    (136 days)

    Product Code
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    PFIZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following: - Moistening of daily wear soft lenses while on the eyes during the day - Moistening of extended wear soft lenses upon awakening and as needed during the day - Moistening of extended wear soft lenses prior to retiring at night Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.
    Device Description
    Visine for Contacts is specially formulated to use while wearing contact lenses to moisten lenses, soothe, refresh and moisturize dry, irritated eyes. Visine for Contacts is safe and effective for individuals with eyes sensitive to thimerosal. It moistens lenses and helps remove particulate matter that may cause irritation and/or discomfort.
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