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Code · CFR · Title 21 — Food and Drugs · Part 874 — Ear, Nose, and Throat Devices · § 874.5300

§ 874.5300. Ear, nose, and throat examination and treatment unit.

101 words·~1 min read·/us/cfr/t21/s§ 874.5300·

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(a)Identification. An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]
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