Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart F - Obstetrical and Gynecological Therapeutic Devices / § 884.5070 Vacuum abortion system.
§ 884.5070 Vacuum abortion system.
(a) Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
(b) Classification. Class II (performance standards).