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

    TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS

    K Number: K861552 · Decision Jun 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    52

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    Basic Information

    Device Name
    TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS
    K Number
    K861552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Entech, Inc.
    Date Received
    April 25, 1986
    Decision Date
    June 16, 1986
    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 Entech, Inc.

    K Number Device Name
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    K890430 ENTAINER(TM) ENTERAL FEEDING CONTAINER
    K873343 ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
    K873444 ENTECH ENTERAL PUMP AND SET
    K871019 ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
    K861427 ENTUBE TM, ENTERAL FEEDING TUBE