ESH — Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane Class II

FDA Device Classification

FDA product code ESH covers "Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.