ENCOMPAS COMFORT BLOCK # 0B-10

ENCOMPAS COMFORT BLOCK # 0B-10 is an FDA 510(k)-cleared medical device (K933537) manufactured by Encompas Unlimited, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 1994. Regulation: 8.