BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇪 Germany

    Thermoforming Sheet Materials

    K Number: K200125 · Decision Oct 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    281

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    Basic Information

    Device Name
    Thermoforming Sheet Materials
    K Number
    K200125
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erkodent Erich Kopp GmbH
    Date Received
    January 21, 2020
    Decision Date
    October 28, 2020
    Product Code
    MQC
    Advisory Committee
    Unknown
    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
    MQC Mouthguard, Prescription

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