K-number	K181069
Device name	Disposable Insulin Pen Needle
Applicant	Zhejiang Kindly Medical Devices Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Aug 28, 2018
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Insulin Pen Needle

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