510(k) K900388

MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES by Midas Rex Pneumatic Tools, Inc. — Product Code HBE

K900388 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.