21 CFR 878.3590 — Prosthesis, Ear, Internal
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3590
Identification
An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FZD | Prosthesis, Ear, Internal | 2 | 3 | Implant |
