K-number	K192374
Device name	Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip
Applicant	Cardinal Health200, LLC
Product code	FXX
Device class	Class II
Decision date	Dec 2, 2019
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip

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Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip