SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL is an FDA 510(k)-cleared medical device (K073684) manufactured by Sheffield Industries, Div. of Faria , Ltd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 21, 2008. Regulation: 8.