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

    TRIEX-1 HOLLOW FIBER DIALYZER

    K Number: K760781 · Decision Dec 6, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    69
    Review Days
    62

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    Basic Information

    Device Name
    TRIEX-1 HOLLOW FIBER DIALYZER
    K Number
    K760781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    October 5, 1976
    Decision Date
    December 6, 1976
    Product Code
    FJT
    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
    FJT Intracatheter, Dialysis

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