Name: Predicase
Price: 199 USD

K-number	K221196
Device name	Disposable Medical Face Mask (ear loop)
Applicant	Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Jul 22, 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 Medical Face Mask (ear loop)

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