K-number	K143446
Device name	Accu-Chek FlexLink Plus infusion set
Applicant	Roche Diagnostics GmbH
Product code	FPA
Device class	Class II
Decision date	Aug 13, 2015
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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Accu-Chek FlexLink Plus infusion set

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