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

    HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER

    K Number: K963727 · Decision Feb 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    9
    Review Days
    148

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    Basic Information

    Device Name
    HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
    K Number
    K963727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Xomed
    Date Received
    September 16, 1996
    Decision Date
    February 11, 1997
    Product Code
    ETD
    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
    ETD Tube, Tympanostomy

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