STAYEREC SYSTEM(TM)

STAYEREC SYSTEM(TM) is an FDA 510(k)-cleared medical device (K901318) manufactured by Osbon Medical Systems, Ltd.. 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 May 3, 1990. Regulation: 8.