510(k) K880601

WIRE PASS DRILL BITS by Nuell Air Equipment & Hospital Supplies, Inc. — Product Code HBE

K880601 is an FDA 510(k) premarket notification submitted by Nuell Air Equipment & Hospital Supplies, Inc. for the device "WIRE PASS DRILL BITS". The FDA issued a decision of Substantially Equivalent on May 6, 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.