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

    DIALYZER, MAGNIFLO 100 PARALLEL PLATE

    K Number: K781966 · Decision Feb 21, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    43
    Review Days
    89

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    Basic Information

    Device Name
    DIALYZER, MAGNIFLO 100 PARALLEL PLATE
    K Number
    K781966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Erika, Inc.
    Date Received
    November 24, 1978
    Decision Date
    February 21, 1979
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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