21 C.F.R. § 878.4025 Silicone sheeting.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4025 Silicone sheeting.
