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e-CFR data is current as of August 4, 2020

Title 21Chapter ISubchapter HPart 876Subpart F → §876.5665


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices


§876.5665   Water purification system for hemodialysis.

(a) Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

(b) Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]

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