510(k) K070018

UNIVERSAL SURGICAL MESH, MODEL 100 by Generic Medical Device, Inc. — Product Code FTL

K070018 is an FDA 510(k) premarket notification submitted by Generic Medical Device, Inc. for the device "UNIVERSAL SURGICAL MESH, MODEL 100". The FDA issued a decision of Substantially Equivalent on April 27, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Generic Medical Device, Inc. has at least 3 other 510(k) clearances on record.