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510(k) Data Aggregation

    K Number
    K150857
    Device Name
    Banana Gold
    Manufacturer
    HANKOOK LATEX GONGUP CO., LTD.
    Date Cleared
    2015-08-14

    (136 days)

    Product Code
    HISBAN
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANKOOK LATEX GONGUP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Personal hygienic medical devices for contraception and preventing from sexually transmitted disease.
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