K-Y BRAND ULTRA GEL PERSONAL LUBRICANT

K-Y BRAND ULTRA GEL PERSONAL LUBRICANT is an FDA 510(k)-cleared medical device (K020827) manufactured by Personal Products Co., Div. of Mcneil Ppc, Inc.. 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 June 11, 2002. Regulation: 8.