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Mantra Intl. (Hk) , Ltd.
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MANTRA COMBO, MODEL MECS 320 is an FDA 510(k)-cleared medical device (K091236) manufactured by Mantra Intl. (Hk) , Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2009. Regulation: 8.