§878.4025. Silicone sheeting.
21 C.F.R. § 878.4025
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
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.
Notes, amendments, and revision history
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]