21 C.F.R. § 874.5550 Powered nasal irrigator.
Title 21 - Food and Drugs
(a) Identification. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (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]
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart F—Therapeutic Devices
§ 874.5550 Powered nasal irrigator.
