SIMS SILO NEEDLE DE-ACCESS ENCLOSURE

SIMS SILO NEEDLE DE-ACCESS ENCLOSURE is an FDA 510(k)-cleared medical device (K935767) manufactured by Sims Deltec, Inc.. 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 November 14, 1995. Regulation: 8.