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CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR884.4260]
 See Related Information on 884.4260 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart E--Obstetrical and Gynecological Surgical Devices

Sec. 884.4260 Hygroscopic Laminaria cervical dilator.

(a)Identification. A hygroscopicLaminaria 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 orLaminaria japonica). The device is used to induce abortion.

(b)Classification. Class II (performance standards).

 
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