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Re: chevyman post# 47113

Friday, 09/09/2011 2:23:54 PM

Friday, September 09, 2011 2:23:54 PM

Post# of 59551
The FDA would accept a new 510(K) if Dean Janes could address and answer all of the questions and do all the "LIVE" clinical testing that the FDA had asked him to do. But, it has been years and Janes still has not answered any of the questions that the FDA wants to know. It does not look as though Dean Janes will be resubmitting a new 510(K) any time soon!!