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    K Number
    K030340
    Device Name
    AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
    Manufacturer
    CYTOMEDIX
    Date Cleared
    2003-04-11

    (70 days)

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

    CYTOMEDIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).
    Device Description
    The AutoloGel Process Centrifuge consists of a table-top, non self-decanting, rotor spin centrifuge and processing disposables designed to allow for rapid automatic separation of plasma and red blood cells from a small volume of whole blood. The centrifuge spins at a maximum speed of 7200 rpms producing a maximum force of approximately 4227 g.
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