K-number	K112267
Device name	NEUROLAC(R) NERVE GUIDE
Applicant	Polyganics B.V.,
Product code	JXI
Device class	Class II
Decision date	Oct 20, 2011
Decision	Substantially Equivalent
Regulation	882.5275

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Source

View the full FDA submission: accessdata.fda.gov

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NEUROLAC(R) NERVE GUIDE

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