Title 21

SECTION 878.4025

878.4025 Silicone sheeting.

§ 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 of this chapter subject to the limitations in § 878.9.

[69 FR 48148, Aug. 9, 2004]