K-number	K142990
Device name	Insta-Gard Surgical and Procedure Face Mask
Applicant	Cardinal Health200, LLC
Product code	FXX
Device class	Class II
Decision date	Mar 4, 2015
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Insta-Gard Surgical and Procedure Face Mask

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