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ChesapeakePaddler

09/02/10 9:42 PM

#25460 RE: Not a Pumper #25459

Not a Pumper - Given:
1. That within the next week, 150 days will have expired since the last submission
2. That within the past 2 quarters, yea or nay has been given to 100% of the 501(k) applicants within 150 days of application.
3. That approximately 97% of the 501(k) applicants have in the past been determined to be SE.
4. That near the end of this 150 day period, Dean contacted the FDA and was told that they needed no more information to make their decision.
I may conclude that there is a very high probability that the IMGG application will be approved within the next week. Exactly what that probability may be is open to debate, but that it is a high probability can hardly be debated. I still say WOW.