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Re: None

Tuesday, 09/06/2011 10:52:42 AM

Tuesday, September 06, 2011 10:52:42 AM

Post# of 59549
I wonder if Dean sent in his formal request to the FDA for a 510K presubmission meeting. I think I heard that when the FDA receives it and date stamps it, the clock will start for a 90 day review period to determine if the request is SA (substantially approved) of NSA (not substantially approved). On the other hand, the FDA might issue to Dean a request for an AAK (additional ass kissing)during which the clock will stop until the request is fully complied with. LOL