§ 876.5450. Rectal dilator.
87 words·~1 min read·
/us/cfr/t21/s§ 876.5450·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
(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 the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001]