H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT

H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT is an FDA 510(k)-cleared medical device (K853366) manufactured by Holter-Hausner Intl.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 1985. Regulation: 8.