Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 874--EAR, NOSE, AND THROAT DEVICES
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| 874.1 |
Scope. |
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| 874.3 |
Effective dates of requirement for premarket approval. |
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| 874.9 |
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 874.1050 |
Audiometer. |
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| 874.1060 |
Acoustic chamber for audiometric testing. |
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| 874.1070 |
Short increment sensitivity index (SISI) adapter. |
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| 874.1080 |
Audiometer calibration set. |
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| 874.1090 |
Auditory impedance tester. |
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| 874.1100 |
Earphone cushion for audiometric testing. |
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| 874.1120 |
Electronic noise generator for audiometric testing. |
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| 874.1325 |
Electroglottograph. |
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| 874.1500 |
Gustometer. |
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| 874.1600 |
Olfactory test device. |
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| 874.1800 |
Air or water caloric stimulator. |
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| 874.1820 |
Surgical nerve stimulator/locator. |
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| 874.1925 |
Toynbee diagnostic tube. |
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| 874.3300 |
Hearing Aid. |
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| 874.3310 |
Hearing aid calibrator and analysis system. |
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| 874.3320 |
Group hearing aid or group auditory trainer. |
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| 874.3330 |
Master hearing aid. |
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| 874.3375 |
Battery-powered artificial larynx. |
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| 874.3400 |
Tinnitus masker. |
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| 874.3430 |
Middle ear mold. |
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| 874.3450 |
Partial ossicular replacement prosthesis. |
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| 874.3495 |
Total ossicular replacement prosthesis. |
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| 874.3540 |
Prosthesis modification instrument for ossicular replacement surgery. |
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| 874.3620 |
Ear, nose, and throat synthetic polymer material. |
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| 874.3695 |
Mandibular implant facial prosthesis. |
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| 874.3730 |
Laryngeal prosthesis (Taub design). |
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| 874.3760 |
Sacculotomy tack (Cody tack) |
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| 874.3820 |
Endolymphatic shunt. |
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| 874.3850 |
Endolymphatic shunt tube with valve. |
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| 874.3880 |
Tympanostomy tube. |
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| 874.3900 |
Nasal dilator. |
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| 874.3930 |
Tympanostomy tube with semipermeable membrane. |
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| 874.3950 |
Transcutaneous air conduction hearing aid system. |
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| 874.4100 |
Epistaxis balloon. |
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| 874.4140 |
Ear, nose, and throat bur. |
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| 874.4175 |
Nasopharyngeal catheter. |
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| 874.4250 |
Ear, nose, and throat electric or pneumatic surgical drill. |
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| 874.4350 |
Ear, nose, and throat fiberoptic light source and carrier. |
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| 874.4420 |
Ear, nose, and throat manual surgical instrument. |
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| 874.4490 |
Argon laser for otology, rhinology, and laryngology. |
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| 874.4500 |
Ear, nose, and throat microsurgical carbon dioxide laser. |
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| 874.4680 |
Bronchoscope (flexible or rigid) and accessories. |
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| 874.4710 |
Esophagoscope (flexible or rigid) and accessories. |
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| 874.4720 |
Mediastinoscope and accessories. |
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| 874.4750 |
Laryngostroboscope. |
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| 874.4760 |
Nasopharyngoscope (flexible or rigid) and accessories. |
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| 874.4770 |
Otoscope. |
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| 874.4780 |
Intranasal splint. |
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| 874.4800 |
Bone particle collector. |
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| 874.5220 |
Ear, nose, and throat drug administration device. |
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| 874.5300 |
Ear, nose, and throat examination and treatment unit. |
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| 874.5350 |
Suction antichoke device. |
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| 874.5370 |
Tongs antichoke device. |
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| 874.5550 |
Powered nasal irrigator. |
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| 874.5800 |
External nasal splint. |
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| 874.5840 |
Antistammering device. |