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

    ULTRACON ULTRAFILTRATOR

    K Number: K981253 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    25
    Review Days
    249

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    Basic Information

    Device Name
    ULTRACON ULTRAFILTRATOR
    K Number
    K981253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interpore Intl.
    Date Received
    April 6, 1998
    Decision Date
    December 11, 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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