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

    Youjia Unscented Tampon with Plastic Applicators

    K Number: K192557 · Decision Feb 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    149

    Basic Information

    Device Name
    Youjia Unscented Tampon with Plastic Applicators
    K Number
    K192557
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qingdao Youjia Hygiene Technology Co., Ltd.
    Date Received
    September 17, 2019
    Decision Date
    February 13, 2020
    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 Qingdao Youjia Hygiene Technology Co., Ltd.

    K Number Device Name
    K190218 Unscented Menstrual Tampon