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

    AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT

    K Number: K123716 · Decision Apr 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    14
    Review Days
    136

    Basic Information

    Device Name
    AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
    K Number
    K123716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Received
    December 4, 2012
    Decision Date
    April 19, 2013
    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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