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

    CARL ZEISS INN MYRINGOTOMY TUBE LINE

    K Number: K811698 · Decision Aug 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    114
    Applicant Total
    5
    Review Days
    76

    Basic Information

    Device Name
    CARL ZEISS INN MYRINGOTOMY TUBE LINE
    K Number
    K811698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    JAMES L. GERACI & ASSOCIATES, INC.
    Date Received
    June 16, 1981
    Decision Date
    August 31, 1981
    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 JAMES L. GERACI & ASSOCIATES, INC.

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