Saturday, July 21, 2007 6:20:51 PM
The FDA is fickle and difficult to nail a solid time frame. I have personally filed three 510k's and they shortest was 90 days the longest 6 months. The SEC in our submission required me to inform investors it could take up to 2 years, which is more typical of class III invasive devices requiring extensive clinical studies. Anyway, lets hope for the best and plan for the worst as government agencies defy logic.
Dean
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