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Thursday, November 19, 2009 2:42:16 PM
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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