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Microaire Surgical Instruments, Inc.
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MICROAIRE 1000E SYSTEM is an FDA 510(k)-cleared medical device (K014060) manufactured by Microaire Surgical Instruments, 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 March 4, 2002. Regulation: 8.