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

    KOTEX STICK TAMPONS, REGULAR AND SUPER

    K Number: K872018 · Decision Jun 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    104
    Review Days
    29

    Basic Information

    Device Name
    KOTEX STICK TAMPONS, REGULAR AND SUPER
    K Number
    K872018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Kimberly-Clark Corp.
    Date Received
    May 26, 1987
    Decision Date
    June 24, 1987
    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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    K112805 KIMGUARD ONE-STEP STERILIZATION WRAP
    K113423 KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
    K112300 KIMGUARD SMART-FOLD* STERILIZATION WRAP
    K112635 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
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