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chevyman

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chevyman

Re: None

Thursday, 09/08/2011 2:29:35 PM

Thursday, September 08, 2011 2:29:35 PM

Post# of 59549
Dr mugs wrote....."Janes can not give the FDA these results because his device is a total sham!! The FDA believes that the real time "3D fluoroscopy" and 3D diagnostic imaging indications constitute a new intended use." I believe these two sentences are contradicting for the DVIS...how can it be a sham, and a new intended use?
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