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510(k) Data Aggregation

    K Number
    K040335
    Device Name
    MOONCUP, STYLE A & B
    Manufacturer
    MOONCUP LLC
    Date Cleared
    2005-03-30

    (413 days)

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

    MOONCUP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MoonCup® 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 MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes: Style A - After childbirth; Style B Before childbirth and/or C-section. The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup.
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