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

    MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

    K Number: K043027 · Decision Dec 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    25
    Review Days
    29

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    Basic Information

    Device Name
    MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
    K Number
    K043027
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    November 3, 2004
    Decision Date
    December 2, 2004
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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