K-number	K210431
Device name	ReCross
Applicant	Imds Operations B.V.
Product code	DQY
Device class	Class II
Decision date	Jul 15, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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ReCross

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