Name: Predicase
Price: 199 USD

K-number	K210147
Device name	Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
Applicant	Unicoglobal, Inc.
Product code	FXX
Device class	Class II
Decision date	Dec 22, 2021
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

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