
Nakanishi, Inc.
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PRIMADO2 TOTAL SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K132264) manufactured by Nakanishi, 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 December 16, 2013. Regulation: 8.

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