510(k) K023342

NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG by Hdc Corp. — Product Code KOI

K023342 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG". The FDA issued a decision of Substantially Equivalent on March 2, 2004. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Hdc Corp. has at least 10 other 510(k) clearances on record.