4 SURE EXTERNAL MALE CATHETER

4 SURE EXTERNAL MALE CATHETER is an FDA 510(k)-cleared medical device (K896726) manufactured by The Boston & Pacific Co., Inc.. 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 February 25, 1990. Regulation: 8.