4 SURE TM COLOSTOMY POUCH

4 SURE TM COLOSTOMY POUCH is an FDA 510(k)-cleared medical device (K922401) manufactured by Boston Pacific Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 9, 1992. Regulation: 8.