510(k) K032115

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 by Polyganics B.V., — Product Code JXI

K032115 is an FDA 510(k) premarket notification submitted by Polyganics B.V., for the device "NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03". The FDA issued a decision of Substantially Equivalent on October 10, 2003. 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.