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In order to get all these approvals, businesses can take help from medical device consultant firms. 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.  Feel free to surf to my site;  http://www.socialleadfreaksoftware.com/