K-number	K221957
Device name	Savewo ClassicMASK
Applicant	Savewo Limited
Product code	FXX
Device class	Class II
Decision date	Sep 2, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Savewo ClassicMASK

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