Name: Predicase
Price: 199 USD

K-number	K191355
Device name	3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
Applicant	3M Healthcare
Product code	FXX
Device class	Class II
Decision date	Sep 11, 2019
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask

Everything you need for a 510(k) submission. Nothing you don't.

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask