Name: Predicase
Price: 199 USD

K-number	K210698
Device name	ECOMA Level 2 Disposable Surgical Mask with Ear Loops
Applicant	Xianning Eco Medical Articles Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Aug 19, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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ECOMA Level 2 Disposable Surgical Mask with Ear Loops

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