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BEES 2.0

This product uses traction to assist the human body's natural ability to change and develop under physical influence. 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.  Here is my site ...  https://slater.co.nz/blogs/slater-chartered-accountants/35922497-free-xero-training-hamilton-nz