K-number	K213632
Device name	Instylla Delivery Kit
Applicant	Instylla, Inc.
Product code	FMF
Device class	Class II
Decision date	Feb 10, 2022
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Instylla Delivery Kit

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