Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart E - Obstetrical and Gynecological Surgical Devices / § 884.4260 Hygroscopic Laminaria cervical dilator.
§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a) Identification. A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.
(b) Classification. Class II (performance standards).