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

    TruGuard Custom Tongue and Jaw Positioner

    K Number: K153270 · Decision Mar 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    12
    Review Days
    117

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    Basic Information

    Device Name
    TruGuard Custom Tongue and Jaw Positioner
    K Number
    K153270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionix Development Corp.
    Date Received
    November 12, 2015
    Decision Date
    March 8, 2016
    Product Code
    IYE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYE Accelerator, Linear, Medical

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