510(k) K030163

ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 by Aseptico, Inc. — Product Code EKX

K030163 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925". The FDA issued a decision of Substantially Equivalent on March 3, 2003. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Aseptico, Inc. has at least 10 other 510(k) clearances on record.