STERILE EYE SURGERY KITS

STERILE EYE SURGERY KITS is an FDA 510(k)-cleared medical device (K842990) manufactured by Biological & Environmental Control Laboratories. 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 8, 1985. Regulation: 8.