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

FDA Device Classification

Classification Details

Product Code
ESH
Device Class
Class II
Regulation Number
874.3620
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K771615coe laboratoriesAUDI-SIL EARMOLD MATERIALAugust 30, 1977