SUOENA AFFINITY (TM) MODEL #802

SUOENA AFFINITY (TM) MODEL #802 is an FDA 510(k)-cleared medical device (K921535) manufactured by Coloplast Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 10, 1992. Regulation: 8.