It's an interesting read and should be taken into consideration however, with that said, any application sent to the FDA has to include this information. Think about it.
It's part of the process for the FDA to evaluate the device. You can't just show up there with a device and not be descriptive (labeling) on its intended purposes, usage and possible pitfalls if know.
Mr. Janes is a smart guy and has been a straight shooter so why would someone think that perhaps he is holding out on approval information? I think not.
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