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Utilizing these mechanisms can help US companies obtain reimbursement in Europe faster, bring their products to market sooner and increase their chances of obtaining a specific DRG code at a later stage. Furthermore, you may be able to better track the results of these new processes that you are implementing into your organization to see which processes are more effective. 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.  Take a look at my homepage  http://thedailyroto.com/