Vivos Inc (RDGL): You are saying that Radiogel's risk leve...

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Re: West Coast Snapper post# 53584

Thursday, 01/28/2016 4:44:24 PM

Thursday, January 28, 2016 4:44:24 PM

You are saying that Radiogel's risk level is closer to pregnancy kits, wheelchairs, and condoms for class 2?

Rather than something thats "injectable and sustains life " class 3?

Fda denial letter stated:

"nor do we believe your device is of low to moderate risk and thus eligible for denovo ".

So when the fda says in the official document that they dont believe Radiogel is eligible for denovo the fda is wrong? Or is it a misprint?

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