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

    Somnos Anti-Snoring Mouth Guard

    K Number: K201484 · Decision Nov 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    212
    Applicant Total
    2
    Review Days
    172

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    Basic Information

    Device Name
    Somnos Anti-Snoring Mouth Guard
    K Number
    K201484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koncept Innovators, LLC
    Date Received
    June 4, 2020
    Decision Date
    November 23, 2020
    Product Code
    LRK
    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
    LRK Device, Anti-Snoring

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