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Post# of 59551
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mr_sano

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mr_sano

Re: eagleagain2002 post# 30055

Tuesday, 10/26/2010 11:21:14 AM

Tuesday, October 26, 2010 11:21:14 AM

Post# of 59551
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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