BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS

    K Number: K052959 · Decision Jan 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    98

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    Basic Information

    Device Name
    DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
    K Number
    K052959
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ssl Americas
    Date Received
    October 21, 2005
    Decision Date
    January 27, 2006
    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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    Other Clearances by Ssl Americas

    K Number Device Name
    K072236 DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
    K071626 DUREX PLAY SOFT & SENSUAL LUBRICANT
    K042957 DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
    K040185 DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM