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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of February 13, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER H—MEDICAL DEVICES PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart A—GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B—DIAGNOSTIC DEVICES
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| Acoustic chamber for audiometric testing. |
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| Short increment sensitivity index (SISI) adapter. |
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| Audiometer calibration set. |
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| Auditory impedance tester. |
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| Earphone cushion for audiometric testing. |
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| Electronic noise generator for audiometric testing. |
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| Air or water caloric stimulator. |
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| Surgical nerve stimulator/locator. |
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Subpart C—[RESERVED]
Subpart D—PROSTHETIC DEVICES
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| Wireless air-conduction hearing aid. |
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| Hearing aid calibrator and analysis system. |
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| Tympanic membrane contact hearing aid. |
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| Group hearing aid or group auditory trainer. |
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| Self-fitting air-conduction hearing aid. |
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| Active implantable bone conduction hearing system. |
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| Battery-powered artificial larynx. |
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| Partial ossicular replacement prosthesis. |
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| Total ossicular replacement prosthesis. |
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| Prosthesis modification instrument for ossicular replacement surgery. |
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| Ear, nose, and throat synthetic polymer material. |
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| Mandibular implant facial prosthesis. |
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| Laryngeal prosthesis (Taub design). |
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| Sacculotomy tack (Cody tack) |
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| Endolymphatic shunt tube with valve. |
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| Tympanostomy tube with semipermeable membrane. |
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| Transcutaneous air conduction hearing aid system. |
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Subpart E—SURGICAL DEVICES
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| Ear, nose, and throat bur. |
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| Eustachian tube balloon dilation system. |
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| Ear, nose, and throat electric or pneumatic surgical drill. |
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| Ear, nose, and throat fiberoptic light source and carrier. |
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| Ear, nose, and throat manual surgical instrument. |
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| Argon laser for otology, rhinology, and laryngology. |
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| Ear, nose, and throat microsurgical carbon dioxide laser. |
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| Bronchoscope (flexible or rigid) and accessories. |
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| Esophagoscope (flexible or rigid) and accessories. |
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| Mediastinoscope and accessories. |
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| Nasopharyngoscope (flexible or rigid) and accessories. |
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Subpart F—THERAPEUTIC DEVICES
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| Ear, nose, and throat drug administration device. |
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| Ear, nose, and throat examination and treatment unit. |
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| Suction antichoke device. |
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| External upper esophageal sphincter compression device. |
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