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510(k) Data Aggregation

    K Number
    K971114
    Device Name
    BIOACCESS MARROW HARVEST SYSTEM
    Manufacturer
    BIOACCESS, INC.
    Date Cleared
    1997-06-03

    (69 days)

    Product Code
    GDM
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOACCESS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
    Device Description
    The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.
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