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

    ENEMA BULB

    K Number: K904534 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    ENEMA BULB
    K Number
    K904534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    R.A.C., Inc.
    Date Received
    October 4, 1990
    Decision Date
    December 21, 1990
    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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