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

    IRRIGATOR, BODY CAVITY

    K Number: K781918 · Decision Feb 15, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    13
    Review Days
    94

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    Basic Information

    Device Name
    IRRIGATOR, BODY CAVITY
    K Number
    K781918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Bci, Inc.
    Date Received
    November 13, 1978
    Decision Date
    February 15, 1979
    Product Code
    EYN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EYN Tray, Irrigation, Sterile

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