ENDOSCOPIC CAMERA TC804/C4

ENDOSCOPIC CAMERA TC804/C4 is an FDA 510(k)-cleared medical device (K014158) manufactured by World of Medicine Lemke GmbH. 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 13, 2002. Regulation: 8.