510(k) K930229

CLINICAL NEURO SYSTEMS CRANIAL DRILL by Clinical Neuro Systems, LLC — Product Code HBE

K930229 is an FDA 510(k) premarket notification submitted by Clinical Neuro Systems, LLC for the device "CLINICAL NEURO SYSTEMS CRANIAL DRILL". The FDA issued a decision of Substantially Equivalent on March 16, 1993. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Clinical Neuro Systems, LLC has at least 4 other 510(k) clearances on record.