I have recently worked on a 510k clearance for a Class II OTC device. The manufacturer has several distributors of the product but wants a single initial importer. I am not that experienced in this area so I would like some guidance. I have noted a number of companies claiming to act as a single entity initial importer and wondered if anyone had any experience of using such a company.
Thanks
Steve
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Steve Baker
i-SMART Consulting US
US +1 267 432 1045
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