Code of Federal Regulations · Section
§ 876.5470 — Ureteral Dilator
21 C.F.R. § 876.5470
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(a) Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351