Name: Predicase
Price: 199 USD

K-number	K202697
Device name	United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
Applicant	United Sewing Automation, Inc.
Product code	FXX
Device class	Class II
Decision date	May 13, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

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