K-number	K163457
Device name	NeuraGen 3D Nerve Guide Matrix
Applicant	Integra LifeSciences Corporation
Product code	JXI
Device class	Class II
Decision date	Jan 6, 2017
Decision	Substantially Equivalent
Regulation	882.5275

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Source

View the full FDA submission: accessdata.fda.gov

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NeuraGen 3D Nerve Guide Matrix

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