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With so many, and so many cost-free, options to network and to distribute your messages, you can now amortize the cost of those efforts that aren't cost-free--website development; literature writing, design, and printing; or exhibit booth development, for example--across more applications. 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.  Feel free to visit my weblog -  http://www.videomotionpro662.org/