510(k) K062758

OWL URF-3AP by Diros Technology, Inc. — Product Code GXD

K062758 is an FDA 510(k) premarket notification submitted by Diros Technology, Inc. for the device "OWL URF-3AP". The FDA issued a decision of Substantially Equivalent on September 27, 2006. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Diros Technology, Inc. has at least 7 other 510(k) clearances on record.