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System, Documentation, Breast Lesion

FDA product code NKA · 2 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.2990
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-06-28 – 2019-07-16

A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.

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