{"data":{"id":"us/21-cfr-878.4025","jurisdiction":"us","citation":"21 CFR 878.4025","heading":"Silicone sheeting.","body":"(a) Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e923c37f3f9bc9a1d4bcc2fb000699085cfe761c47d59ac80e2a245bc26803fa","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4022","next":"us/21-cfr-878.4040"},"notice":"GroundRules: Original legal text. Not legal advice."}