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Re: A deleted message

Tuesday, 11/16/2010 12:49:22 PM

Tuesday, November 16, 2010 12:49:22 PM

Post# of 59551
Denunzio your not buying Deans administrative issue theory are you? What exactly does that mean...? Hey look I'm saying i believe there is some issue with design and or safety. Its a spinning mass shooting out an ionized beam. If the predicate device is not configured in the same manner with like controls then it has to be NSE. Dean must now prove it safe and prove his special controls. It can then be downgraded to class 1-11. The whole "off the shelf" concept Dean floated out is now really full of holes. The FDA has looked at Dean predicate and said it's not the same. Next case.