HESSLER COLON THERAPY DEVICE

HESSLER COLON THERAPY DEVICE is an FDA 510(k)-cleared medical device (K800565) manufactured by Hessler Mfg. Co.. 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 June 25, 1980. Regulation: 8.