510(k) K905097

MICRO-AIRE MODEL NUMBER: MK-426 by Micro Surgical Instruments Corp. — Product Code HBE

K905097 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "MICRO-AIRE MODEL NUMBER: MK-426". The FDA issued a decision of Substantially Equivalent on December 21, 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 Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.