SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT

SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT is an FDA 510(k)-cleared medical device (K052162) manufactured by Sheffield Laboratories, Div. of Faria Limited, LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2006. Regulation: 8.