K-number	K192464
Device name	Injection Pen Needle
Applicant	Gangan Medical Technology Jiangsu Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Aug 25, 2020
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Injection Pen Needle

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