HYPER-INFLATION BAG

HYPER-INFLATION BAG is an FDA 510(k)-cleared medical device (K942571) manufactured by Med-Plastics Intl., Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 1994. Regulation: 8.