K-number	K191853
Device name	Dual-Safety Pen Needle
Applicant	Promisemed Hangzhou Meditech Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Sep 5, 2019
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Dual-Safety Pen Needle

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