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pendragon8062

09/24/10 12:32 PM

#27717 RE: kimble1 #27715

On the other hand, you have to set your expectations to what the show allows.

1. You can't see a demonstration of the device.
2. You won't see any materials that were not included as part of the 510k (if SE is not granted by the show)

So what you will see is Mike, Dean, the shell, and the static marketing materials as they were when the 510k process started (or as of the April 5th resubmission). I3 may also choose to omit details that could give a competitor ideas on your secret sauce.

If you are the competition, you are there to talk about your device, not whether you are scared of the competition. So you put your poker face on, talk up your device, and if someone asks "What about Bob over there?" you nod your head a little and say "Bob's got a nice product." and end the conversation. Doesn't matter if it's a legitimate threat to your market or not.

Now if they have approval prior to RSNA, it's a whole different ballgame of course.