Name: Predicase
Price: 199 USD

K-number	K203078
Device name	CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
Applicant	Huizhou Tianchang Industrial Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Aug 19, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

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