MODIFIED SITE TXR SYSTEMS

MODIFIED SITE TXR SYSTEMS is an FDA 510(k)-cleared medical device (K925828) manufactured by Site Microsurgical Systems, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 1994. Regulation: 8.