K-number	K240258
Device name	Disposable Medical Face Mask (M643BE)
Applicant	Makrite Industries, Inc.
Product code	FXX
Device class	Class II
Decision date	Apr 18, 2024
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Medical Face Mask (M643BE)

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