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

    GIL-MED PARENTERAL NUTRITION OR MEDICINE

    K Number: K841597 · Decision Oct 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    7
    Review Days
    191

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    Basic Information

    Device Name
    GIL-MED PARENTERAL NUTRITION OR MEDICINE
    K Number
    K841597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gil-Med Industries C/O Kegan & Kegan, Ltd.
    Date Received
    April 18, 1984
    Decision Date
    October 26, 1984
    Product Code
    KPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPE Container, I.V.

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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
    K861862 DIETO CONTAINER FOR ENTERAL NUTRITION
    K841224 URO-MALE INCONTINENCE CATHETER
    K840915 DIMIX CONTAINER FOR PARNETERAL NUTRIT
    K840916 DIETO CONTAINER FOR ENTERNAL NUTRIT