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Gold Seeker

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Re: HALF FULL GLASS post# 5909

Friday, 10/27/2006 6:51:22 AM

Friday, October 27, 2006 6:51:22 AM

Post# of 30387
Wittenberg was addressing the uninformed about what was not needed to get the product approved. Anyone that knows anything about the FDA knows that devices do not have to go through the typical phase I, II,or(IIB), III that are required of drugs. A test is a DEVICE and come under different rules. You have to do a 510k or a PMA whichever is appropriate. So what he said was not "good news" or in fact not any kind of news at all, just fact.

Yes, I do know a lot about the FDA, trials, etc.

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