K-number	K223003
Device name	Banded Face Mask
Applicant	Hubei Medlink Healthcare Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Nov 18, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Banded Face Mask

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