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

    DUMON TRACHEOBRONCHIAL STENT

    K Number: K894380 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    DUMON TRACHEOBRONCHIAL STENT
    K Number
    K894380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bryan Corp.
    Date Received
    July 17, 1989
    Decision Date
    October 24, 1989
    Product Code
    NWA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NWA Prosthesis, Tracheal, Preformed/Molded

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