K-number	K121170
Device name	RESIN 11
Applicant	Respinnovation Sas
Product code	BYI
Device class	Class II
Decision date	Jul 13, 2012
Decision	Substantially Equivalent
Regulation	868.5665

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Source

View the full FDA submission: accessdata.fda.gov

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RESIN 11

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