COVER-ALL MALE INCONTINENCE DEVICE

COVER-ALL MALE INCONTINENCE DEVICE is an FDA 510(k)-cleared medical device (K801629) manufactured by The Urology Group. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1980. Regulation: 8.