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

    GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS

    K Number: K880083 · Decision Jan 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    86
    Review Days
    15

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    Basic Information

    Device Name
    GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
    K Number
    K880083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gambro, Inc.
    Date Received
    January 12, 1988
    Decision Date
    January 27, 1988
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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