K-number	K221178
Device name	Disposable Insulin Pen Needle
Applicant	Ningbo Medsun Medical Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Nov 17, 2022
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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