21 CFR 876.5450 - Rectal dilator.

§ 876.5450 Rectal dilator.

(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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code