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

    HYDRO-SAN COLONIC IRRIGATION SYSTEM

    K Number: K891585 · Decision Aug 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    HYDRO-SAN COLONIC IRRIGATION SYSTEM
    K Number
    K891585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Specialty Health Products, Inc.
    Date Received
    March 20, 1989
    Decision Date
    August 3, 1989
    Product Code
    KPL
    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
    KPL Colonic Irrigation System

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