SCLERAL PLUGS, 19 AND 20 GAUGE

SCLERAL PLUGS, 19 AND 20 GAUGE is an FDA 510(k)-cleared medical device (K990872) manufactured by Ophthalmic Consultants, 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 July 12, 1999. Regulation: 8.