BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    LARGE/EXTRA LAGRE CONDOM

    K Number: K113061 · Decision Dec 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    54

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    Basic Information

    Device Name
    LARGE/EXTRA LAGRE CONDOM
    K Number
    K113061
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Karex Industries Sdn. Bhd.
    Date Received
    October 14, 2011
    Decision Date
    December 7, 2011
    Product Code
    HIS
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIS Condom

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