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

    ENTERAL FEEDING BAG, 1000 ML, & TUBING SET

    K Number: K851975 · Decision Sep 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    8
    Review Days
    121

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    Basic Information

    Device Name
    ENTERAL FEEDING BAG, 1000 ML, & TUBING SET
    K Number
    K851975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Venusa , Ltd.
    Date Received
    May 7, 1985
    Decision Date
    September 5, 1985
    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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    K905518 BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
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    K812981 FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
    K811914 FLU VEN I.V. SETS