Code of Federal Regulations · Section

§ 878.4025 — Silicone Sheeting

21 C.F.R. § 878.4025

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(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.

21 C.F.R. § 878.4022 21 C.F.R. § 878.4040

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