STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN

STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN is an FDA 510(k)-cleared medical device (K933424) manufactured by Zyloware Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 19, 1993. Regulation: 8.