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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 874Subpart D → §874.3620


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices


§874.3620   Ear, nose, and throat synthetic polymer material.

(a) Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

(b) Classification. Class II.

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