510(k) K961113

CNS INTERCHANGEABLE BIT CRANIAL DRILL by Clinical Neuro Systems, LLC — Product Code HBG

K961113 is an FDA 510(k) premarket notification submitted by Clinical Neuro Systems, LLC for the device "CNS INTERCHANGEABLE BIT CRANIAL DRILL". The FDA issued a decision of Substantially Equivalent on June 5, 1996. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Clinical Neuro Systems, LLC has at least 4 other 510(k) clearances on record.