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Wednesday, April 06, 2011 10:00:12 AM
The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer. The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted.
This is as good as it get's!
vibe
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