RENASYS AB ABOMINAL DRESSING KIT

RENASYS AB ABOMINAL DRESSING KIT is an FDA 510(k)-cleared medical device (K112784) manufactured by Smith & Nephew, Inc.. 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 November 21, 2011. Regulation: 8.