SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE is an FDA 510(k)-cleared medical device (K904151) 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 December 4, 1990. Regulation: 8.