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510(k) Data Aggregation

    K Number
    K120555
    Device Name
    LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
    Manufacturer
    MEDICAL-LATEX (DUA) SDN. BHD
    Date Cleared
    2012-11-02

    (253 days)

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

    MEDICAL-LATEX (DUA) SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
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