K-number	K200767
Device name	SilverStream Gel
Applicant	Enzysurge , Ltd.
Product code	FRO
Device class	Class U
Decision date	Oct 8, 2020
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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SilverStream Gel

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