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510(k) Data Aggregation

    K Number
    K971268
    Device Name
    BONE & MARROW CLLECTION SYSTEM
    Manufacturer
    BIOMEDICAL INTERNATIONAL CORP.
    Date Cleared
    1997-07-03

    (87 days)

    Product Code
    GEY
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMEDICAL INTERNATIONAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.
    Device Description
    Bone and Marrow Collection System (BMCS)
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