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

    MCGEE MODIFIED STAINLESS STEEL PISTON

    K Number: K823440 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    80
    Review Days
    17

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    Basic Information

    Device Name
    MCGEE MODIFIED STAINLESS STEEL PISTON
    K Number
    K823440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Treace Medical, Inc.
    Date Received
    November 16, 1982
    Decision Date
    December 3, 1982
    Product Code
    ETB
    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
    ETB Prosthesis, Partial Ossicular Replacement

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