CENEFOM PVA SURGICAL SPEAR

CENEFOM PVA SURGICAL SPEAR is an FDA 510(k)-cleared medical device (K082460) manufactured by Longtek Scientific Co., Ltd.. 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 14, 2008. Regulation: 8.