510(k) K193144

T-Line Hernia Mesh by Deep Blue Medical Advances, Inc. — Product Code FTL

K193144 is an FDA 510(k) premarket notification submitted by Deep Blue Medical Advances, Inc. for the device "T-Line Hernia Mesh". The FDA issued a decision of Substantially Equivalent on March 30, 2020. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Deep Blue Medical Advances, Inc. has at least 3 other 510(k) clearances on record.