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Alias Born 02/17/2010

Re: None

Thursday, 08/26/2010 11:00:07 AM

Thursday, August 26, 2010 11:00:07 AM

Post# of 59550
The new 150 day FDA decision time limit has no binding to I3. Everyone is so stuck on this 150 day limit and think Sept 9th or 8th is the day. I3's submission to the FDA was before this 150 day limit was put into motion by the FDA. Any 510k submitted before 150 day limit rule doesn't follow the rule. The FDA has as long as they want to drag this out. Everyone needs to chill on this damn Sept date, when the date passes you will all freak.