K-number	K160101
Device name	SinuBand
Applicant	Bioinspire Technologies, Incorporated
Product code	QJL
Device class	Class I
Decision date	Jul 27, 2016
Decision	Substantially Equivalent
Regulation	874.4780

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Source

View the full FDA submission: accessdata.fda.gov

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SinuBand

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