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    K Number
    K140626
    Device Name
    MELUNA CLASSIC/SPORT MENSTRUAL CUP
    Manufacturer
    MELUNA
    Date Cleared
    2014-07-10

    (121 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MELUNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MeLuna Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
    Device Description
    The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications. The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.
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