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

    DIETO CONTAINER FOR ENTERAL NUTRITION

    K Number: K861862 · Decision Aug 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    DIETO CONTAINER FOR ENTERAL NUTRITION
    K Number
    K861862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gil-Med Industries C/O Kegan & Kegan, Ltd.
    Date Received
    May 13, 1986
    Decision Date
    August 11, 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 Gil-Med Industries C/O Kegan & Kegan, Ltd.

    K Number Device Name
    K880506 MODIFIED EVA-MIX AND DI-MIX BAGS
    K870274 DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER
    K841597 GIL-MED PARENTERAL NUTRITION OR MEDICINE
    K841224 URO-MALE INCONTINENCE CATHETER
    K840915 DIMIX CONTAINER FOR PARNETERAL NUTRIT
    K840916 DIETO CONTAINER FOR ENTERNAL NUTRIT