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In order to get all these approvals, businesses can take help from medical device consultant firms. "yet another knee implant", or do you want them thinking "reproducible surgical technique" or "happy patients, returning to their normal, active lifestyle. 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 web site:  http://www.videomakerfxdownload.com/