510(k) K081272

PORCINE SURGICAL MESH; DERMAL MATRIX by Brennen Medical, LLC — Product Code FTM

K081272 is an FDA 510(k) premarket notification submitted by Brennen Medical, LLC for the device "PORCINE SURGICAL MESH; DERMAL MATRIX". The FDA issued a decision of Substantially Equivalent on July 31, 2008. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Brennen Medical, LLC has at least 10 other 510(k) clearances on record.