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BEES 2.0

If the expected service is sufficient to justify listing for reimbursement, the guidance of CNEDi - MTS will also be based on the ASA in relation to a comparable product, considered to be the current gold standard, whether or not this gold standard is reimbursed. 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.  Feel free to surf to my web site;  https://www.thenora.co.uk/collections/bags