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

    2.5 FRENCH LITHOTRIPTOR ELECTRODE

    K Number: K894704 · Decision Oct 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    8
    Review Days
    85

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    Basic Information

    Device Name
    2.5 FRENCH LITHOTRIPTOR ELECTRODE
    K Number
    K894704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Northgate Research, Inc.
    Date Received
    July 25, 1989
    Decision Date
    October 18, 1989
    Product Code
    FFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFK Lithotriptor, Electro-Hydraulic

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