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Re: kimble1 post# 14628

Monday, 05/03/2010 1:33:55 PM

Monday, May 03, 2010 1:33:55 PM

Post# of 59549
Is it the "supplemental" info Mr. Janes said he sent that has you worried? I personally thing a PMA would be ridiculous in this case and I'm convinced that the 510k is teh right application under which this device should be filed. But the "supplemental" statement stood out in my mind as more info that would take more time for the FDA to examine. Hopefully I'm just being paranoid and this is just the FDA being thorough, hopefully in a timely manner.