Name: Predicase
Price: 199 USD

K-number	K220597
Device name	Disposable Surgical Face Mask (FM-34EE,FM-44EE)
Applicant	Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	May 26, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Surgical Face Mask (FM-34EE,FM-44EE)

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