510(k) K903664

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL by Micro-Aire Surgical Instruments, Inc. — Product Code HBE

K903664 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL". The FDA issued a decision of Substantially Equivalent on September 13, 1990. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.