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

    FLUSHING IRRIGATION SET

    K Number: K923497 · Decision Mar 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    33
    Review Days
    614

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    Basic Information

    Device Name
    FLUSHING IRRIGATION SET
    K Number
    K923497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Orion Life Systems, Inc.
    Date Received
    July 15, 1992
    Decision Date
    March 21, 1994
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

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