K-number	K193422
Device name	Easydrip Pen Needle, Easydrip Plus Pen Needle
Applicant	Sandstone Medical (Suzhou), Inc.
Product code	FMI
Device class	Class II
Decision date	Feb 2, 2021
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Easydrip Pen Needle, Easydrip Plus Pen Needle

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