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U.S. Department of Health and Human Services

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, 2013]
[CITE: 21CFR884]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 884OBSTETRICAL AND GYNECOLOGICAL DEVICES
 

Subpart D--Obstetrical and Gynecological Prosthetic Devices

Sec. 884.3200 Cervical drain.

(a)Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.

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

Sec. 884.3575 Vaginal pessary.

(a)Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

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

Sec. 884.3650 Fallopian tube prosthesis.

(a)Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.

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

Sec. 884.3900 Vaginal stent.

(a)Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

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

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted.

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