Vivos Inc (RDGL)

[Kaveli]

keep in mind if it isn't classified as class 2 they will get class 3 again and start marketing internationally while they start work on the class 2 again. However it will be, the de novo process skips the 501k part and the company worked closely with the FDA leading up to the submission of the de novo getting everything in order and compliance with what the FDA is looking for