eCFR Reference Browser

---

title: "21 CFR §874.3620"

source: "https://www.ecfr.gov/current/title-21/section-874.3620"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "874"

part_subject: "EAR, NOSE, AND THROAT DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "874.3620"

section_subject: "Ear, nose, and throat synthetic polymer material."

cfr_reference: "21 CFR 874.3620"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

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