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Re: GetSeriousOK post# 80583

Saturday, 07/23/2016 5:38:08 PM

Saturday, July 23, 2016 5:38:08 PM

Post# of 329048
To continue to hang on to the idea that this is De Novo is desperate and completely inaccurate. They are clearly in talks with the FDA about 510(k), not De Novo. There are no secrets they are holding back. Even the FDA believes 510(k) is now the appropriate path to be pursuing. That is why the studies have been asked for and accepted. Completely valid and complete enough clinical data to have the FDA accept.

Those are the facts and cannot be spun negatively. For those who continue to spin against the facts being presented completely discredit themselves.