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Title 21 → Chapter I → Subchapter H → Part 876 → Subpart F → §876.5895

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

§876.5895 Ostomy irrigator.

(a) Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.

(b) Classification. Class II (special controls). The device 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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