K-number	K202899
Device name	Procedure Mask, Surgical Mask
Applicant	Kenpax International Limited
Product code	FXX
Device class	Class II
Decision date	May 20, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Procedure Mask, Surgical Mask

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