SITE PHACO DISPOSABLE CASSETTE

SITE PHACO DISPOSABLE CASSETTE is an FDA 510(k)-cleared medical device (K861060) 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 May 5, 1986. Regulation: 8.