Vivos Inc (RDGL): Maybe its the classification problem....

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Re: Chief Slapaho post# 52183

Thursday, 12/24/2015 5:31:04 PM

Thursday, December 24, 2015 5:31:04 PM

Maybe its the classification problem.

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm

Fda has examples of class 1,2, and 3 devices and explanations of each classification group.

It appears denovo will not work. Maybe investors are scared this will be submitted wrong again as a denovo when that's not even the write classification group- it can only be class 3 pma.

Another good reason denovo won't work, is because denovo DIDN'T WORK.

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