1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 878 - GENERAL AND PLASTIC SURGERY DEVICES
  6. Subpart E - Surgical Devices
  7. 21 CFR § 878.4025
21 CFR § 878.4025
Silicone sheeting
June 25, 2020
CFR

(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]

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