No dmurphydrtcthe, letter is dated (sorry I did not paste it) as 12 April 2007. It is a one year follow up to the initial inspection, noting they still have not complied.
Here is the link:
http://www.fda.gov/foi/warning_letters/s6340c.htm
CHeers
HGR
unknown
requirements for fda 510k, page-6
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