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Medtronic Neurosurgery
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STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 is an FDA 510(k)-cleared medical device (K083076) 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 November 19, 2008. Regulation: 8.