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

    PIGGYBACK IRRIGATING SYSTEM

    K Number: K040094 · Decision Apr 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    PIGGYBACK IRRIGATING SYSTEM
    K Number
    K040094
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kosin Technologies, LLC
    Date Received
    January 16, 2004
    Decision Date
    April 15, 2004
    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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