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Furthermore, many companies simply don't have the money to make all of the changes and meet all the other demands asked of them in order to bring their product up to meet FDA standards. 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.  Also visit my homepage:  http://www.schuttingen-tuinhout.nl/