Name: Predicase
Price: 199 USD

K-number	K202319
Device name	Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
Applicant	Tianjin Huahong Technology Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Nov 12, 2021
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 (Ordinary Type), Insulin Pen Needle (Safety Type)

Everything you need for a 510(k) submission. Nothing you don't.