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

    U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS

    K Number: K103311 · Decision Dec 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
    K Number
    K103311
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly Clark Corporation
    Date Received
    November 10, 2010
    Decision Date
    December 10, 2010
    Product Code
    HEB
    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
    HEB Tampon, Menstrual, Unscented

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