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    FDA 510(k) FDA class 2 Unknown 🇸🇪 Sweden

    The Cooral System

    K Number: DEN210027 · Decision Oct 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    469

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    Basic Information

    Device Name
    The Cooral System
    K Number
    DEN210027
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    872.5590
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Braincool AB
    Date Received
    July 2, 2021
    Decision Date
    October 14, 2022
    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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