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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. If I were to ask you, "Who is the buyer of your medical devices. 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 webpage:  http://www.conniescakesicles.com/