UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT

UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT is an FDA 510(k)-cleared medical device (K892215) manufactured by Codman & Shurtleff, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 1989. Regulation: 8.