JOE LUB HELMET CONDOM

JOE LUB HELMET CONDOM is an FDA 510(k)-cleared medical device (K011378) manufactured by Marketing Sales Concepts, Inc. (Msci). 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 March 24, 2002. Regulation: 8.