STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM

STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K924685) manufactured by Leibinger GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 1994. Regulation: 8.