HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L is an FDA 510(k)-cleared medical device (K994198) manufactured by Toray Industries (America), Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2000. Regulation: 8.