KENSEY NASH ECM SURGICAL PATCH

KENSEY NASH ECM SURGICAL PATCH is an FDA 510(k)-cleared medical device (K094061) manufactured by Kensey Nash Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 2010. Regulation: 8.