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NeuroPace, Inc.
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NEUROPACE BURR HOLE COVER MODEL 8110 is an FDA 510(k)-cleared medical device (K123163) manufactured by NeuroPace, 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 January 17, 2013. Regulation: 8.