
Dura Tap, LLC
Free shipping on orders over $99 · 30-day returns
Gazelle PTFE and Suture Delivery Device is an FDA 510(k)-cleared medical device (K173335) manufactured by Dura Tap, LLC. 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 February 7, 2018. Regulation: 8.