---
kind: "section"
citation: "21 C.F.R. § 878.4025"
title: "21"
number: "878.4025"
heading: "Silicone sheeting."
url: "https://uscodex.org/cfr/21/878.4025"
---

# §878.4025. Silicone sheeting.

- (a) **Identification.** Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 878.9](/cfr/21/878.9.md).

## Notes

### Amendments

[69 FR 48148, Aug. 9, 2004]

### 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.

### Amendments

[69 FR 48148, Aug. 9, 2004]