510(k) K093196

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 by Cousin Biotech Sas — Product Code FTL

K093196 is an FDA 510(k) premarket notification submitted by Cousin Biotech Sas for the device "BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Cousin Biotech Sas has at least 6 other 510(k) clearances on record.