1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 878
  5. subpart E
  6. § 878.4025

View all text of Subpart E [§ 878.4010 - § 878.5050]

§ 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]

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

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

CITE AS: 21 CFR 878.4025