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Medtronic Neurosurgery
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STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 is an FDA 510(k)-cleared medical device (K082127) manufactured by Medtronic Neurosurgery. 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 26, 2008. Regulation: 8.