K-number	K192112
Device name	FlexBand Plus
Applicant	International Life Sciences
Product code	FTL
Device class	Class II
Decision date	Sep 27, 2019
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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FlexBand Plus

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