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

    HOLLOW FIBER DIALYZER HOLDER

    K Number: K802075 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    20

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    Basic Information

    Device Name
    HOLLOW FIBER DIALYZER HOLDER
    K Number
    K802075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Renal Devices, Inc.
    Date Received
    August 27, 1980
    Decision Date
    September 16, 1980
    Product Code
    FKI
    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
    FKI Set, Dialyzer Holder

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    Other Clearances by Renal Devices, Inc.

    K Number Device Name
    K810612 HEMOPHRON
    K801559 HOLLO FIBER DIALYZER
    K790696 RDI-1 HOLLOW FIBER DIALYZER