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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 884: OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart C: Obstetrical and Gynecological Monitoring Devices
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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