They have no manufacturing capability they are a service lab that does repair and refurbishing. Sorry these two are much different. They need to be certified to work on the devices so thats the extent of any audit thats being circulated as news. Do they audit 510K applicants that are not set up for manufacturing...just in case they want to ramp it up after approval? This is unrelated to the 510K. Spinning this into something its not is pretty much standard operating procedure for many.
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