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510(k) Data Aggregation

    K Number
    K991049
    Device Name
    CLIMAX
    Manufacturer
    MEDILATEX SDN. BHD.
    Date Cleared
    1999-06-15

    (77 days)

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

    MEDILATEX SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CLIMAX condom is used for contraception and for prophylactic purposes( to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    CLIMAX Male Natural Rubber Latex Condom
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