SHELHIGH NO-REACT PERICARDIAL PATCHES

SHELHIGH NO-REACT PERICARDIAL PATCHES is an FDA 510(k)-cleared medical device (K974914) 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 June 2, 1998. Regulation: 8.