510(k) K091325

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS by Cooper Surgical — Product Code KGI

K091325 is an FDA 510(k) premarket notification submitted by Cooper Surgical for the device "TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Cooper Surgical has at least 5 other 510(k) clearances on record.