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Extensive and ongoing training in how to use and interpret data is regulated. IMAGE - Before you go any further, you must decide what primary message you want your audience to associate with your name. The question pertains to approval in Europe, Australia, Japan, Canada and how that relates to a US approval, and secondly, what type of 510(k) to prepare in the US.  My web blog  http://www.videomotionpro662.org/