ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K942187) 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 July 27, 1994. Regulation: 8.