SENSATION -VACUUM ASSIST DEVICES

SENSATION -VACUUM ASSIST DEVICES is an FDA 510(k)-cleared medical device (K000124) manufactured by Prosurg, 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 July 9, 2000. Regulation: 8.