K-Y BRAND WARMING JELLY PERSONAL LUBRICANT

K-Y BRAND WARMING JELLY PERSONAL LUBRICANT is an FDA 510(k)-cleared medical device (K040164) manufactured by Personal Products Company, 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 April 4, 2004. Regulation: 8.