510(k) K071695

KENSEY NASH MACROPORE SHIELD by Kensey Nash Corp. — Product Code FTL

K071695 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "KENSEY NASH MACROPORE SHIELD". The FDA issued a decision of Substantially Equivalent on December 31, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.