Name: Predicase
Price: 199 USD

K-number	K211827
Device name	Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Applicant	Zhejiang Lanhine Medical Products, Ltd.
Product code	FXX
Device class	Class II
Decision date	Sep 23, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

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