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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. IMAGE - Before you go any further, you must decide what primary message you want your audience to associate with your name. 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.  Review my web site;  http://www.conniescakesicles.com/