Name: Predicase
Price: 199 USD

K-number	K211832
Device name	Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
Applicant	Zhejiang Lanhine Medical Products, Ltd.
Product code	FXX
Device class	Class II
Decision date	Sep 8, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

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