PEDIA-THOR THORACOSTOMY KIT

PEDIA-THOR THORACOSTOMY KIT is an FDA 510(k)-cleared medical device (K913540) manufactured by Intl. Medical Devices , Ltd.. 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 April 8, 1992. Regulation: 8.