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 D - Prosthetic Devices
  7. 21 CFR § 878.3590
21 CFR § 878.3590
Ear prosthesis
June 25, 2020
CFR

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.

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§ 878.3550 Chin prosthesis
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§ 878.3610 Esophageal prosthesis

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