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510(k) Data Aggregation

    K Number
    K990669
    Device Name
    MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
    Manufacturer
    DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD.
    Date Cleared
    1999-05-17

    (76 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THESE DIFFERENT TYPES (NATURAL ORDINARY, NATURAL RIBBED, NATURAL DOTTED, AND NATURAL CONTOURED) OF NATURAL LATEX RUBBER CONDON (WITH NONOXYNOL-9) ARE USED FOR CONTRACEPTION AND FOR PROPHYLACTIC PURPOSES (TO PREVENT PREGNANCY AND THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD'S).
    Device Description
    Natural Ordinary, Natural Ribbed, Natural Dotted and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9)
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