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

    ENEMA KIT

    K Number: K913620 · Decision Nov 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    ENEMA KIT
    K Number
    K913620
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    York County Blind Center
    Date Received
    August 13, 1991
    Decision Date
    November 1, 1991
    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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