NOVUS STANDARD AND PEDIATRIC VALVES

NOVUS STANDARD AND PEDIATRIC VALVES is an FDA 510(k)-cleared medical device (K961859) manufactured by Integra Neurocare, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 1996. Regulation: 8.