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Friday, October 02, 2009 6:53:46 AM
pieces coming together... he ain't blowing smoke... he most definitely has in-roads laid...
remember he has been instrumental in developing the CCD camera for fluoroscopes...
and has prior 510K experience...
read this clearance letter for one of those 510K clearances...when imaging3 was imaging services.
pay attention to the second paragraph...
http://www.accessdata.fda.gov/cdrh_docs/pdf/k010772.pdf
just my two cents on some deductive reasoning for my dd.
but here's some more...
take a look at this article on it...3rd paragarph.
and note the title, "...FDA works through a backlog of submissions." some things never change huh...
http://www.diagnosticimaging.com/radiation-oncology/article/113619/1218772?pageNumber=2&verify=0
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