K-number	K211440
Device name	ASM-301 Level 3 Surgical Mask
Applicant	American Surgical Mask Company, LLC
Product code	FXX
Device class	Class II
Decision date	Jun 2, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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ASM-301 Level 3 Surgical Mask

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