
Salumedica, LLC
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SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 is an FDA 510(k)-cleared medical device (K100382) manufactured by Salumedica, LLC. 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 4, 2010. Regulation: 8.