BIOELAST 5-0 SUTURE, MODEL 500100

BIOELAST 5-0 SUTURE, MODEL 500100 is an FDA 510(k)-cleared medical device (K072470) manufactured by Entrigue Surgical, Inc.. 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 November 15, 2007. Regulation: 8.