AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**

AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** is an FDA 510(k)-cleared medical device (K952748) manufactured by United States Surgical, A Division of Tyco Healthc. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 1995. Regulation: 8.