SHELHIGH NO-REACT VASCUPATCH

SHELHIGH NO-REACT VASCUPATCH is an FDA 510(k)-cleared medical device (K982810) manufactured by Shelhigh, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 1998. Regulation: 8.