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TASHI

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TASHI

Re: csmith post# 2582

Monday, 02/02/2009 4:07:08 PM

Monday, February 02, 2009 4:07:08 PM

Post# of 59549
csmith,

I haven't recently read anything on the FDA as it relates to the 510k & IDE procedures. My thoughts back in April 2008 were that the IDE process was a more streamlined approach towards an expedited device clearance at the end of the 510k.

Here's a link that I posted in April 2008. This FDA link is dated 01/20/1998...

http://www.fda.gov/cdrh/ode/idepolcy.html


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