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510(k) Data Aggregation
K Number
K151090Device Name
CPL Insulin Pen Needle
Manufacturer
Date Cleared
2016-09-21
(517 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
CPL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is a single use sterile insulin pen-injector needle to be used by diabetic patients for the purpose of injecting insulin.
Device Description
CPL insulin pen needle consist of a sterile cap, needle, hub and blister paper. The sterile cap and blister 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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