EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS is an FDA 510(k)-cleared medical device (K972994) 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 November 2, 1997. Regulation: 8.