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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR878.4025]
See Related Information on Silicone sheeting. in CDRH databases



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

Sec. 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.

[69 FR 48148, Aug. 9, 2004]

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