K-number	K173424
Device name	BioSphere Flex
Applicant	Synergy Biomedical
Product code	MQV
Device class	Class II
Decision date	Sep 12, 2018
Decision	Substantially Equivalent
Regulation	888.3045

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Source

View the full FDA submission: accessdata.fda.gov

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BioSphere Flex

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