LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113061
    Device Name
    LARGE/EXTRA LAGRE CONDOM
    Manufacturer
    KAREX INDUSTRIES SDN BHD.
    Date Cleared
    2011-12-07

    (54 days)

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

    KAREX INDUSTRIES SDN BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karex Large and Extra Large condom is used for contraceptive and for . prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1