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Alias Born 12/10/2009

Re: None

Tuesday, 08/23/2011 12:45:08 PM

Tuesday, August 23, 2011 12:45:08 PM

Post# of 59551
THE FDA STATES ......The information requested in the A.I. letters and in the NSE rejection letter are issues that they believe need to be resolved before a review of a NEW 510K submission can be successfully completed. So, there you have it folks...Dean Janes can not submit a new application until he answers all of the questions that the FDA wants answered. This is proof that a new 510K will never ever be filed. This information can be found on the last page of the FDA NSE letter.