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

    OTOLOGICAL VENTILATION TUBES

    K Number: K802587 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    OTOLOGICAL VENTILATION TUBES
    K Number
    K802587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Humboldt Products
    Date Received
    October 20, 1980
    Decision Date
    November 12, 1980
    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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    Hummingbird Tympanostomy Tube System

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    Other Clearances by Humboldt Products

    K Number Device Name
    K832540 DRUMTO STAPES PROSTHESIS
    K823483 STAINLESS STEEL PISTONS
    K813616 TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
    K812562 SURGICAL RETRACTOR & ELASTIC STAYS, DISP