
Integra Neurosciences Implants S.A.
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EQUI-FLOW VALVE AND SHUNT SYSTEM is an FDA 510(k)-cleared medical device (K042558) manufactured by Integra Neurosciences Implants S.A.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 2004. Regulation: 8.