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510(k) Data Aggregation

    K Number
    K991206
    Device Name
    BONASSE CONTACT LENS CASE
    Manufacturer
    BONASSE ENT. CO., LTD.
    Date Cleared
    2000-06-06

    (424 days)

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

    BONASSE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.
    Device Description
    The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles include a lens basket used for holding the lens during storage.
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