BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇬 Egypt

    CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

    K Number: K982337 · Decision Dec 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    2
    Review Days
    176

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    Basic Information

    Device Name
    CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
    K Number
    K982337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haidylena Medical Egypt
    Date Received
    July 6, 1998
    Decision Date
    December 29, 1998
    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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