K-number	K242502
Device name	Aurelia Surgical Mask ASTM Level-3 (2130)
Applicant	Supermax Healthcare Canada Supermax Medical
Product code	FXX
Device class	Class II
Decision date	Nov 12, 2024
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Aurelia Surgical Mask ASTM Level-3 (2130)

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