BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Unscented Menstrual Tampon

    K Number: K232598 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    4
    Review Days
    109

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    Basic Information

    Device Name
    Unscented Menstrual Tampon
    K Number
    K232598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unibeauty (Hubei) Technology Co., Ltd.
    Date Received
    August 28, 2023
    Decision Date
    December 15, 2023
    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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    Other Clearances by Unibeauty (Hubei) Technology Co., Ltd.

    K Number Device Name
    K253719 Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
    K252613 Unscented menstrual three-piece applicator tampon
    K251033 Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons