510(k) K862523

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS by Walter Lorenz Surgical, Inc. — Product Code EKW

K862523 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS". The FDA issued a decision of Substantially Equivalent on Aug 1, 1986. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.