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

    TEFLON FEMORAL CATHETER MWI 100,10 &

    K Number: K831828 · Decision Jul 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    11
    Review Days
    30

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    Basic Information

    Device Name
    TEFLON FEMORAL CATHETER MWI 100,10 &
    K Number
    K831828
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Med-West, Inc.
    Date Received
    June 7, 1983
    Decision Date
    July 7, 1983
    Product Code
    LFK
    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
    LFK Catheter, Femoral

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