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510(k) Data Aggregation

    K Number
    K122700
    Device Name
    PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
    Manufacturer
    PROSBEN, INC.
    Date Cleared
    2013-05-31

    (269 days)

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

    PROSBEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only; not to be used with heat.
    Device Description
    The PROSBEN Contact Lens Case is the subject of this 510(k) premarket notification. The Contact Lens Case is a lens care product to be used the contact lens wearer or practitioner for storing contact lenses while not being worn. The PROSBEN Contact Lens Cases are designed for use in chemical disinfection only; not to be used with heat. The PROSBEN Contact Lens Cases are not including the disinfection, only for shipping the cases in a dry state.
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