K-number	K212514
Device name	Safety Pen Needle for Single Use, Insulin Pen Needles
Applicant	Berpu Medical Technology Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Apr 29, 2022
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Safety Pen Needle for Single Use, Insulin Pen Needles

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