K-number	K160648
Device name	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
Applicant	Unomedical A/S
Product code	FPA
Device class	Class II
Decision date	Aug 10, 2016
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

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