BEUDAMED
    FDA 510(k) Substantially Equivalent 🇧🇪 Belgium

    Pixie Skin Tag

    K Number: K240226 · Decision Oct 18, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Pixie Skin Tag
    K Number
    K240226
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oystershell NV
    Date Received
    January 26, 2024
    Decision Date
    October 18, 2024
    Product Code
    ORE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N