BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VIVONEX MASS GASTRASTOMY TUBE

    K Number: K822516 · Decision Sep 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    10
    Review Days
    18

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VIVONEX MASS GASTRASTOMY TUBE
    K Number
    K822516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5370
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Norwich Eaton Pharmaceuticals, Inc.
    Date Received
    August 20, 1982
    Decision Date
    September 7, 1982
    Product Code
    KHT
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHT Fraction V, Antigen, Antiserum, Control

    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-
    K821231 VIVONEX TUNGSTEN TIP TUBE PLACEMENT
    K821067 VIVONEX ACUTROL ENTERNAL FEEDING SYS
    K811968 VIVONEX TUNGSTEN TIP
    K802300 VIVONEX JEJUNOSTOMY KIT