MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER

MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER is an FDA 510(k)-cleared medical device (K012374) manufactured by Astra Tech, 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 August 22, 2001. Regulation: 8.