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

    MCLEAN-STOCK PERCUTANEOUS T-TUBE SET

    K Number: K921654 · Decision Jul 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    190
    Review Days
    86

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    Basic Information

    Device Name
    MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
    K Number
    K921654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cook, Inc.
    Date Received
    April 7, 1992
    Decision Date
    July 2, 1992
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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