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    K Number
    K093813
    Device Name
    OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
    Manufacturer
    IMBIOTECHNOLOGIES
    Date Cleared
    2010-05-10

    (150 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMBIOTECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.
    Device Description
    The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.
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