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510(k) Data Aggregation

    K Number
    K983480
    Device Name
    BPOS-IVAD STABILIZER
    Manufacturer
    BPOS, INC.
    Date Cleared
    1998-11-23

    (52 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    BPOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.
    Device Description
    The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area.
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