CFR
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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.
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