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

    DUREX COLORS AND SCENTS

    K Number: K980174 · Decision Aug 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    205

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    Basic Information

    Device Name
    DUREX COLORS AND SCENTS
    K Number
    K980174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    London Intl., LLC
    Date Received
    January 20, 1998
    Decision Date
    August 13, 1998
    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 London Intl., LLC

    K Number Device Name
    K982924 DUREX SENSIDOM LATEX CONDOM
    K983380 DUREX LUBRAGEL LATEX CONDOM
    K980785 STERILE, POWDERFREE LATEX EXAMINATION GLOVE
    K980319 DUREX ULTRA COMFORT
    K980204 DUREX LATEX CONDOMS