
Simbionix , Ltd.
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PROCEDURE REHEARSAL STUDIO(TM) is an FDA 510(k)-cleared medical device (K112387) manufactured by Simbionix , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2011. Regulation: 8.