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Thursday, September 02, 2010 4:12:47 PM
Slide 45 of the video:
"We have this regulation about confidentiality really on the existence of a 510(k) application. We don't make it known publically that we have a 510(k) application under review, and we don't make anything known to the public other than those that we find SE. . . ."
All those clamoring for Dean to release more specifics about the content of the application and the specifics about what the Reviewer is communicating to Imaging3 need to understand that this is a confidential process.
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