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510(k) Data Aggregation

    K Number
    K974485
    Device Name
    SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
    Manufacturer
    SZABOCSIK AND ASSOC.
    Date Cleared
    1998-02-24

    (90 days)

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

    SZABOCSIK AND ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by the eye care practitioner.
    Device Description
    A sterile, isotonic solution that contains Poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.
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