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

    95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

    K Number: K974090 · Decision Aug 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    42
    Review Days
    302

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    Basic Information

    Device Name
    95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
    K Number
    K974090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    October 29, 1997
    Decision Date
    August 27, 1998
    Product Code
    MSE
    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
    MSE Hemodialyzer, Re-Use, Low Flux

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