INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE is an FDA 510(k)-cleared medical device (K060413) manufactured by Intact Medical Corporation. 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 April 26, 2006. Regulation: 8.