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

    MERIT DRAINAGE DEPOT

    K Number: K003078 · Decision Dec 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    8
    Applicant Total
    178
    Review Days
    69

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    Basic Information

    Device Name
    MERIT DRAINAGE DEPOT
    K Number
    K003078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    October 3, 2000
    Decision Date
    December 11, 2000
    Product Code
    EXF
    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
    EXF Bag, Bile Collecting

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