What Is This Device?
external aesthetic restoration prosthesis
What Is FDA Product Code NOJ?
Prosthesis, Breast, External, No Adhesive is FDA product code NOJ, Class 1, 21 CFR 878.3800.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.