K-number	K202615
Device name	Nordiwell Medical Face Mask
Applicant	Changzhou Combat Protective Equipment Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Dec 31, 2020
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Nordiwell Medical Face Mask

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