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

    SHILEY DISPOS. DECANNULATION PLUG W/SW/

    K Number: K843730 · Decision Oct 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    127
    Applicant Total
    174
    Review Days
    25

    Basic Information

    Device Name
    SHILEY DISPOS. DECANNULATION PLUG W/SW/
    K Number
    K843730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    SHILEY, INC.
    Date Received
    September 24, 1984
    Decision Date
    October 19, 1984
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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