Code of Federal Regulations · Section
§ 884.4260 — Hygroscopic Laminaria Cervical Dilator
21 C.F.R. § 884.4260
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351