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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. "Go opt-in, multi-touch and multi-channel with your marketing. 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.  Here is my web blog -  https://slater.co.nz/blogs/slater-chartered-accountants/35922497-free-xero-training-hamilton-nz