Name: Predicase
Price: 199 USD

K-number	K213450
Device name	Medical surgical mask (Black mask, Level 1 and Level 3)
Applicant	Guangdong Kingfa Sci. & Tech.Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Apr 5, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Medical surgical mask (Black mask, Level 1 and Level 3)

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