Safe'n'Sound Staked Passive Delivery System - Plajex version

Safe'n'Sound Staked Passive Delivery System - Plajex version is an FDA 510(k)-cleared medical device (K150562) manufactured by Nemera. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2015. Regulation: 8.