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adrian taylor

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adrian taylor

Re: vibetech1 post# 32852

Monday, 11/29/2010 9:25:56 AM

Monday, November 29, 2010 9:25:56 AM

Post# of 59551
The only way the FDA would ever accept a re-submission of a 510-K is with attached sucessful clinical trial data. This "additional information" does not currently exist and would take a minimum of a year to a year and a half to complete and only if the DViS really works.
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