K-number	K212095
Device name	SurGuard3 Safety Hypodermic Needle
Applicant	Terumo Europe N.V.
Product code	FMI
Device class	Class II
Decision date	Aug 22, 2022
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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SurGuard3 Safety Hypodermic Needle

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