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Re: None

Wednesday, 02/23/2011 6:14:49 PM

Wednesday, February 23, 2011 6:14:49 PM

Post# of 59551
It's now clear why Dean Janes can’t show the Dominion in action. He would be in violation of the Act per the FDA. Read page 8-20.

http://viewer.zoho.com/docs/d0dTh

Excerpt:
You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.

KF