ESF — Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent Class II

FDA Device Classification

FDA product code ESF covers "Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent", a Class II medical device regulated under 21 CFR 878.3500. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.