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

    SOLID STATE CONTINUOUS FLOW CONTROL

    K Number: K822743 · Decision Sep 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    SOLID STATE CONTINUOUS FLOW CONTROL
    K Number
    K822743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Widran Urological Group, Ltd.
    Date Received
    September 10, 1982
    Decision Date
    September 24, 1982
    Product Code
    LJH
    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
    LJH System, Irrigation, Urological

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    Other Clearances by Widran Urological Group, Ltd.

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    K861460 SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101