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510(k) Data Aggregation

    K Number
    K070666
    Device Name
    GENESISCS COMPONENT CONCENTRATING SYSTEM
    Manufacturer
    PERFUSION PARTNERS & ASSOC. INC.
    Date Cleared
    2007-06-20

    (100 days)

    Product Code
    JQC
    Regulation Number
    862.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PERFUSION PARTNERS **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.
    Device Description
    Not Found
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    K Number
    K024080
    Device Name
    SECQUIRE CELL SEPARATOR
    Manufacturer
    PERFUSION PARTNERS & ASSOC. INC.
    Date Cleared
    2003-07-02

    (204 days)

    Product Code
    JQC
    Regulation Number
    862.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PERFUSION PARTNERS **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.
    Device Description
    SECQUIRE Cell Separator
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