K-number	K210860
Device name	Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
Applicant	Gri-Alleset, Inc.
Product code	FXX
Device class	Class II
Decision date	Apr 7, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

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