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Re: None

Monday, 10/08/2018 7:26:18 AM

Monday, October 08, 2018 7:26:18 AM

Post# of 329235
Email response from Paul referencing FDA questions.


From mngt.:

We did receive questions from the FDA and we duly responded last week. The FDA’s goal is to clear 510(k)’s within 90 days, which happens in less than 20% of the time. The average is slightly less than 180 days. New innovative technology always takes longer. The FDA staffs working on our application are highly competent.