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510(k) Data Aggregation

    K Number
    K071079
    Device Name
    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
    Manufacturer
    GAMBRO BCT, INC.
    Date Cleared
    2007-08-02

    (107 days)

    Product Code
    LKN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO BCT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
    Device Description
    Spectra Optia Apheresis System, a blood component separator
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