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510(k) Data Aggregation
K Number
K170846Device Name
Disposable Insulin Pen Needle
Manufacturer
Jiangsu Caina Technology Co., Ltd.
Date Cleared
2017-12-13
(267 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Caina Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Description
The subject device, Disposable Insulin Pen Needle, is a single-use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, inner sheath, outer sheath, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The subject device is not intended for neonates, newborn infants or children. The subject device is used in conjunction with following pen injector during clinical use.
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