SHELHIGH NO-REACT BIOCUFF

SHELHIGH NO-REACT BIOCUFF is an FDA 510(k)-cleared medical device (K032893) manufactured by Shelhigh, 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 December 18, 2003. Regulation: 8.