MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK is an FDA 510(k)-cleared medical device (K831773) manufactured by Bcd Products, 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 August 15, 1983. Regulation: 8.