K-number	K211097
Device name	Banyan USA Surgical Mask Level 3
Applicant	Banyan USA, LLC
Product code	FXX
Device class	Class II
Decision date	Sep 22, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Banyan USA Surgical Mask Level 3

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