510(k) K881418

CRANIOTOME BLADE OR NEURO BLADE by Nuell Air Equipment & Hospital Supplies, Inc. — Product Code HBE

K881418 is an FDA 510(k) premarket notification submitted by Nuell Air Equipment & Hospital Supplies, Inc. for the device "CRANIOTOME BLADE OR NEURO BLADE". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Nuell Air Equipment & Hospital Supplies, Inc. has at least 2 other 510(k) clearances on record.