LINEBERGER EXTERNAL MALE CATHETER

LINEBERGER EXTERNAL MALE CATHETER is an FDA 510(k)-cleared medical device (K800890) manufactured by Lineberger External Catheter Co.. 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 June 19, 1980. Regulation: 8.