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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. And if it does relate, hopefully it's not an ad for a competing product or service. 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.  Have a look at my web page  https://slater.co.nz/blogs/slater-chartered-accountants/35922497-free-xero-training-hamilton-nz