ESH

Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane

Product code: ESH
Device name: Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Device class: Class 2
21 CFR: 21 CFR 874.3620
Medical specialty: Ear, Nose, Throat
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 1

Official FDA classification page: ESH

Classification and pathway per current FDA publications. Data from openFDA (CC0).