K-number	K202998
Device name	Vydence Zye and Vydence One
Applicant	Vydence Medical Industria E Comercio Ltda
Product code	GEX
Device class	Class II
Decision date	Oct 26, 2021
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Vydence Zye and Vydence One

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