510(k) K862852

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR by Micro-Aire Surgical Instruments, Inc. — Product Code GFF

K862852 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR". The FDA issued a decision of Substantially Equivalent on August 11, 1986. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.