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

    GAMBRO LUNDIA COIL DIALYZER

    K Number: K800174 · Decision Feb 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    86
    Review Days
    19

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    Basic Information

    Device Name
    GAMBRO LUNDIA COIL DIALYZER
    K Number
    K800174
    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 25, 1980
    Decision Date
    February 13, 1980
    Product Code
    FHS
    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
    FHS Dialyzer, Single Coil

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