---
kind: "section"
citation: "21 C.F.R. § 878.3590"
title: "21"
number: "878.3590"
heading: "Ear prosthesis."
url: "https://uscodex.org/cfr/21/878.3590"
---

# §878.3590. Ear prosthesis.

- (a) **Identification.** An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
- (b) **Classification.** Class II.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.