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

    SHILEY SPECIALIZED TRACHEOSTOMY TUBE

    K Number: K903435 · Decision Oct 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    107
    Applicant Total
    174
    Review Days
    63

    Basic Information

    Device Name
    SHILEY SPECIALIZED TRACHEOSTOMY TUBE
    K Number
    K903435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    SHILEY, INC.
    Date Received
    July 31, 1990
    Decision Date
    October 2, 1990
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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