K-number	K213407
Device name	UltiCare Disposable Pen Needles
Applicant	Ultimed Incorporated
Product code	FMI
Device class	Class II
Decision date	Dec 16, 2021
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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UltiCare Disposable Pen Needles

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