Code of Federal Regulations · Section
§ 884.1300 — Uterotubal Carbon Dioxide Insufflator And Accessories
21 C.F.R. § 884.1300
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(a) Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351