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

    LARGE VOLUME ENEMA CONTAINER DISPOSABLE

    K Number: K800959 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    29
    Applicant Total
    29
    Review Days
    21

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    Basic Information

    Device Name
    LARGE VOLUME ENEMA CONTAINER DISPOSABLE
    K Number
    K800959
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    April 23, 1980
    Decision Date
    May 14, 1980
    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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