ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K951180) manufactured by Szabocsik and Assoc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 1995. Regulation: 8.