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Tatramed Spol. S.R.O.
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PRAEZIS PLUS is an FDA 510(k)-cleared medical device (K110644) manufactured by Tatramed Spol. S.R.O.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2012. Regulation: 8.