BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VAN JON SUPER CLYSTER(KIT, ENEMA

    K Number: K843792 · Decision Apr 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    207

    Basic Information

    Device Name
    VAN JON SUPER CLYSTER(KIT, ENEMA
    K Number
    K843792
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    VAN JON CO.
    Date Received
    September 27, 1984
    Decision Date
    April 22, 1985
    Product Code
    FCE
    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
    FCE Enema Kit

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