K-number	K222681
Device name	Altaviz Needle Kit
Applicant	Altaviz, LLC
Product code	FMI
Device class	Class II
Decision date	Dec 5, 2022
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Altaviz Needle Kit

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