510(k) K850483

MICRO-AIRE STERNUM SAW REPLACEMENT BLADES by Micro-Aire Surgical Instruments, Inc. — Product Code DWH

K850483 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE STERNUM SAW REPLACEMENT BLADES". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code DWH (Blade, Saw, Surgical, Cardiovascular), 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.