K-number	K240286
Device name	PRIMED Surgical Masks and PRIMED Procedure Masks
Applicant	Primed Medical Products, Inc.
Product code	FXX
Device class	Class II
Decision date	Aug 26, 2024
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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PRIMED Surgical Masks and PRIMED Procedure Masks

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