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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, 2014]
[CITE: 21CFR884.2990]
See Related Information on Breast lesion documentation system. 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 C--Obstetrical and Gynecological Monitoring Devices

Sec. 884.2990 Breast lesion documentation system.

(a) Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.

(b) Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breast Lesion Documentation System." See 884.1(e) for the availability of this guidance document.

[68 FR 44415, Aug. 27, 2003]

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