ORION ALL SILICONE ELASTOMER COATED CATHETER

ORION ALL SILICONE ELASTOMER COATED CATHETER is an FDA 510(k)-cleared medical device (K944376) manufactured by Regulatory & Marketing Services, 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 November 29, 1994. Regulation: 8.