The FDA doesn't want to approve this device, or they already would have by now. It has been more than 3 years. There is something that they don't like. Dean has always known that this 510K was a long shot with the FDA. He has always been nervous when the FDA was ever mentioned. He has always been afraid of "freaking them out". What could possibly freak them out? What does freaking them out really mean here? Could it be a total rejection?
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