510(k) K071470

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX by Implantech Associates, Inc. — Product Code FTL

K071470 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX". The FDA issued a decision of Substantially Equivalent on August 31, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.