People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market. Proregulations provides a range of U.S. medical device 510(k) premarket notification services to help customers reach their goal of selling in the U.S. market as quickly as possible.