PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT is an FDA 510(k)-cleared medical device (K100461) manufactured by Riverpoint Medical. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2010. Regulation: 8.