TRI-STAR UNIVERSAL I/A PHACO PAK

TRI-STAR UNIVERSAL I/A PHACO PAK is an FDA 510(k)-cleared medical device (K953359) manufactured by Tri-Star Ophthalmic. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 1995. Regulation: 8.