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

    SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

    K Number: K930895 · Decision Jul 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    4
    Review Days
    130

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    Basic Information

    Device Name
    SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
    K Number
    K930895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Medical Tpi, Inc.
    Date Received
    February 22, 1993
    Decision Date
    July 2, 1993
    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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    Other Clearances by Mallinckrodt Medical Tpi, Inc.

    K Number Device Name
    K945406 SSV PHONATE(TM) SHILEY SPEAKING VALVE
    K945407 SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
    K936224 REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS