21 C.F.R. PART 874--EAR, NOSE, AND THROAT DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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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| Hearing aid calibrator and analysis system.
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| Group hearing aid or group auditory trainer.
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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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| 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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