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

    K-TUBE REPAIR KIT

    K Number: K840019 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    K-TUBE REPAIR KIT
    K Number
    K840019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Midwest Metabolic Support Group
    Date Received
    January 5, 1984
    Decision Date
    February 10, 1984
    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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    Other Clearances by Midwest Metabolic Support Group

    K Number Device Name
    K843939 PEDIATRIC SIZE K-TUBE A OR B
    K844745 K-TUBE
    K813504 ACESSORY TO MODIFIED FREEDING JEJUNOSTO