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Section 874.1
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Effective dates of requirement for premarket approval |
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Section 874.3
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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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Section 874.9
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Audiometer |
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Section 874.1050
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Acoustic chamber for audiometric testing |
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Section 874.1060
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Short increment sensitivity index (SISI) adapter |
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Section 874.1070
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Audiometer calibration set |
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Section 874.1080
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Auditory impedance tester |
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Section 874.1090
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Earphone cushion for audiometric testing |
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Section 874.1100
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Electronic noise generator for audiometric testing |
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Section 874.1120
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Electroglottograph |
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Section 874.1325
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Gustometer |
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Section 874.1500
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Olfactory test device |
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Section 874.1600
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Air or water caloric stimulator |
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Section 874.1800
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Surgical nerve stimulator/locator |
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Section 874.1820
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Toynbee diagnostic tube |
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Section 874.1925
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Hearing Aid |
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Section 874.3300
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Wireless air-conduction hearing aid |
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Section 874.3305
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Hearing aid calibrator and analysis system |
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Section 874.3310
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Group hearing aid or group auditory trainer |
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Section 874.3320
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Master hearing aid |
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Section 874.3330
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Battery-powered artificial larynx |
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Section 874.3375
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Tinnitus masker |
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Section 874.3400
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Middle ear mold |
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Section 874.3430
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Partial ossicular replacement prosthesis |
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Section 874.3450
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Total ossicular replacement prosthesis |
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Section 874.3495
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Prosthesis modification instrument for ossicular replacement surgery |
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Section 874.3540
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Ear, nose, and throat synthetic polymer material |
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Section 874.3620
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Mandibular implant facial prosthesis |
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Section 874.3695
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Laryngeal prosthesis (Taub design) |
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Section 874.3730
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Sacculotomy tack (Cody tack) |
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Section 874.3760
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Endolymphatic shunt |
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Section 874.3820
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Endolymphatic shunt tube with valve |
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Section 874.3850
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Tympanostomy tube |
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Section 874.3880
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Nasal dilator |
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Section 874.3900
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Tympanostomy tube with semipermeable membrane |
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Section 874.3930
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Transcutaneous air conduction hearing aid system |
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Section 874.3950
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Epistaxis balloon |
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Section 874.4100
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Ear, nose, and throat bur |
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Section 874.4140
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Nasopharyngeal catheter |
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Section 874.4175
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Ear, nose, and throat electric or pneumatic surgical drill |
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Section 874.4250
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Ear, nose, and throat fiberoptic light source and carrier |
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Section 874.4350
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Ear, nose, and throat manual surgical instrument |
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Section 874.4420
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Argon laser for otology, rhinology, and laryngology |
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Section 874.4490
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Ear, nose, and throat microsurgical carbon dioxide laser |
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Section 874.4500
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Bronchoscope (flexible or rigid) and accessories |
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Section 874.4680
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Esophagoscope (flexible or rigid) and accessories |
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Section 874.4710
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Mediastinoscope and accessories |
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Section 874.4720
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Laryngostroboscope |
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Section 874.4750
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Nasopharyngoscope (flexible or rigid) and accessories |
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Section 874.4760
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Otoscope |
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Section 874.4770
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Intranasal splint |
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Section 874.4780
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Bone particle collector |
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Section 874.4800
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Ear, nose, and throat drug administration device |
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Section 874.5220
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Ear, nose, and throat examination and treatment unit |
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Section 874.5300
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Suction antichoke device |
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Section 874.5350
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Tongs antichoke device |
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Section 874.5370
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Powered nasal irrigator |
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Section 874.5550
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External nasal splint |
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Section 874.5800
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Antistammering device |
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Section 874.5840
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Scope |