K-number	K211897
Device name	Surgical Face Mask
Applicant	Zhejiang Hongyu Medicali Commodity Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Aug 3, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Face Mask

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