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510(k) Data Aggregation
K Number
K160199Device Name
Advocate Insulin Pen Needles
Manufacturer
Date Cleared
2016-10-19
(265 days)
Product Code
Regulation Number
880.5570Why 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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