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510(k) Data Aggregation

    K Number
    K023128
    Device Name
    NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    Date Cleared
    2003-01-22

    (125 days)

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

    SECURE SCIENTIFIC SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
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