CFR
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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.
Code of Federal Regulations
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