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

    TEKNA MED MYRINGOTOMY DISPOS-OTO KIT

    K Number: K813616 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
    K Number
    K813616
    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
    December 29, 1981
    Decision Date
    January 22, 1982
    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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    Other Clearances by Humboldt Products

    K Number Device Name
    K832540 DRUMTO STAPES PROSTHESIS
    K823483 STAINLESS STEEL PISTONS
    K812562 SURGICAL RETRACTOR & ELASTIC STAYS, DISP
    K802587 OTOLOGICAL VENTILATION TUBES