510(k) K875224

HUDSON CRANINAL BURRS by Tri-Med, Inc. — Product Code HBE

K875224 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "HUDSON CRANINAL BURRS". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.