K-number	K212302
Device name	BAYLAB 3-Ply Surgical Mask (BEACON I)
Applicant	Baylab USA, LLC
Product code	FXX
Device class	Class II
Decision date	Dec 7, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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BAYLAB 3-Ply Surgical Mask (BEACON I)

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