21 C.F.R. § 884.4260 Hygroscopic Laminaria cervical dilator.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart E—Obstetrical and Gynecological Surgical Devices
§ 884.4260 Hygroscopic Laminaria cervical dilator.