[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.4250]

[Page 438]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
        Subpart E--Obstetrical and Gynecological Surgical Devices
 
Sec. 884.4250  Expandable cervical dilator.

    (a) Identification. An expandable cervical dilator is an instrument 
with two handles and two opposing blades used manually to dilate 
(stretch open) the cervical os.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
expandable cervical dilator that was in commercial distribution before 
May 28, 1976, or that has, on or before December 26, 1996 been found to 
be substantially equivalent to an expandable cervical dilator that was 
in commercial distribution before May 28, 1976. Any other expandable 
cervical dilator shall have an approved PMA or a declared completed PDP 
in effect before being placed in commercial distribution.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987; 61 FR 50708, Sept. 27, 1996]