K-number	K153706
Device name	Insulin Pen Needle
Applicant	SteriLance Medical (Suzhou), Inc.
Product code	FMI
Device class	Class II
Decision date	Aug 29, 2016
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Insulin Pen Needle

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