PROSYS SAMEC LA

PROSYS SAMEC LA is an FDA 510(k)-cleared medical device (K963265) manufactured by Convatec, A Division of E.R. Squibb & Sons. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 24, 1996. Regulation: 8.