§ 878.3500. Polytetrafluoroethylene with carbon fibers composite implant material.
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/us/cfr/t21/s§ 878.3500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.