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Running a business requires a great deal of planning and organisation. The human body and physiology in general are fairly well understood in terms of their basic mechanics. 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 site ... https://slater.co.nz/blogs/slater-chartered-accountants/35922497-free-xero-training-hamilton-nz
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