21 C.F.R. § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
Title 21 - Food and Drugs
(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need. (b) Classification. Class II.
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart D—Prosthetic Devices
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
