BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE is an FDA 510(k)-cleared medical device (K897005) manufactured by Helix Medical, 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 March 15, 1990. Regulation: 8.