AM. PH. STERILE SINGLE-USE URETHRAL CATH

AM. PH. STERILE SINGLE-USE URETHRAL CATH is an FDA 510(k)-cleared medical device (K820419) manufactured by American Pharmaseal Div. Ahsc. 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 March 22, 1982. Regulation: 8.