510(k) K911812

ACRA-CUT WIRE PASS DRILL by Acra Cut, Inc. — Product Code HBE

K911812 is an FDA 510(k) premarket notification submitted by Acra Cut, Inc. for the device "ACRA-CUT WIRE PASS DRILL". The FDA issued a decision of Substantially Equivalent on September 10, 1991. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Acra Cut, Inc. has at least 7 other 510(k) clearances on record.