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510(k) Data Aggregation
K Number
K152334Device Name
Sungshim Insulin Pen Needle
Manufacturer
Date Cleared
2016-03-17
(211 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SUNGSHIM MEDICARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product to be used with insulin injector is a single use sterile insulin pen needle to be used for injecting insulin to patient with diabetes.
Device Description
Sungshim insulin pen needle consist of a Sterile cap, Needle, Hub and Sterile paper. The Primary container and Sterile paper function to sustain sterilization of the product. The Hub can be connected with pen type insulin syringe. The Needle cap protects the Needle. This device is single use.
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