510(k) K003529

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS by Edap Technomed, Inc. — Product Code LNS

K003529 is an FDA 510(k) premarket notification submitted by Edap Technomed, Inc. for the device "SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Edap Technomed, Inc. has at least 4 other 510(k) clearances on record.