510(k) K050573

NEUROLAC NERVE GUIDE by Polyganics B.V., — Product Code JXI

K050573 is an FDA 510(k) premarket notification submitted by Polyganics B.V., for the device "NEUROLAC NERVE GUIDE". The FDA issued a decision of Substantially Equivalent on May 4, 2005. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Polyganics B.V., has at least 8 other 510(k) clearances on record.