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510(k) Data Aggregation

    K Number
    K970648
    Device Name
    PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
    Manufacturer
    RENAL SYSTEMS, INC.
    Date Cleared
    1998-01-05

    (319 days)

    Product Code
    MSF
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.
    Device Description
    Not Found
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