21 C.F.R. § 878.3500

Current through October 31, 2024
Section 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material
(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.

21 C.F.R. §878.3500