BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDNEXT BUR

    K Number: K935584 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    17
    Applicant Total
    7
    Review Days
    96

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    Basic Information

    Device Name
    MEDNEXT BUR
    K Number
    K935584
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4140
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mednext, Inc.
    Date Received
    November 18, 1993
    Decision Date
    February 22, 1994
    Product Code
    EQJ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQJ Bur, Ear, Nose And Throat

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