510(k) K042822

TCM ENDO V, MODEL 1534 by NOUVAG AG — Product Code EKX

K042822 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "TCM ENDO V, MODEL 1534". The FDA issued a decision of Substantially Equivalent on December 22, 2004. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. NOUVAG AG has at least 10 other 510(k) clearances on record.