SHIKANI-FRENCH SPEAKING VALVE

SHIKANI-FRENCH SPEAKING VALVE is an FDA 510(k)-cleared medical device (K982128) manufactured by Pilling Weck Surgical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 1998. Regulation: 8.