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510(k) Data Aggregation

    K Number
    K160199
    Device Name
    Advocate Insulin Pen Needles
    Date Cleared
    2016-10-19

    (265 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diabetic Supply of Suncoast, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
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