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510(k) Data Aggregation

    K Number
    K033163
    Device Name
    CAUTION CONDOMS
    Manufacturer
    RICHARD VAN HAUSSEN AMERICA, INC.
    Date Cleared
    2004-04-27

    (172 days)

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

    RICHARD VAN HAUSSEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
    Device Description
    Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9
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