
Microtek Medical, Inc.
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FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK is an FDA 510(k)-cleared medical device (K102971) manufactured by Microtek Medical, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2011. Regulation: 8.