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

    Chemo Mouthpiece

    K Number: K232917 · Decision Jan 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    Chemo Mouthpiece
    K Number
    K232917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5590
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemo Mouthpiece, LLC
    Date Received
    September 19, 2023
    Decision Date
    January 23, 2024
    Product Code
    QUA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QUA Intraoral Cooling Device

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