ENTAKE STANDARD AND SAFETY PEG SYSTEM

ENTAKE STANDARD AND SAFETY PEG SYSTEM is an FDA 510(k)-cleared medical device (K061021) manufactured by Conmedcorp. 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 April 27, 2006. Regulation: 8.