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

    VIVONEX TUNGSTEN TIP

    K Number: K811968 · Decision Aug 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    10
    Review Days
    46

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    Basic Information

    Device Name
    VIVONEX TUNGSTEN TIP
    K Number
    K811968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Norwich Eaton Pharmaceuticals, Inc.
    Date Received
    July 10, 1981
    Decision Date
    August 25, 1981
    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 Norwich Eaton Pharmaceuticals, Inc.

    K Number Device Name
    K842841 VIVONEX TUNG STEN TIP TUBE
    K831969 VIVONEX TUNGSTEN TIP TUBE-WOUND
    K831968 VIVONEX TUNGSTEN TIP TUBE-BRAIDED
    K831971 VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE
    K831970 VIVONEX TUNGSTEN TIP TUBE-MONOFILA-
    K822516 VIVONEX MASS GASTRASTOMY TUBE
    K821231 VIVONEX TUNGSTEN TIP TUBE PLACEMENT
    K821067 VIVONEX ACUTROL ENTERNAL FEEDING SYS
    K802300 VIVONEX JEJUNOSTOMY KIT