K-number	K182144
Device name	Bi-Flex Evo
Applicant	Promepla Sam
Product code	KNY
Device class	Class II
Decision date	Sep 7, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Bi-Flex Evo

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