WELL LEAD TRACHEOSTOMY TUBE

WELL LEAD TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K042684) manufactured by Well Lead Medical Instruments. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 16, 2005. Regulation: 8.