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Dr. Mugs

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Dr. Mugs

Re: BuyOnDips post# 36190

Monday, 01/24/2011 8:57:56 PM

Monday, January 24, 2011 8:57:56 PM

Post# of 59551
It is very unusual for a 510k to be rejected.. only 3 percent? This rejection is not the fault of the FDA. Dean Janes should have done an IDE years ago. The FDA will never approve this device without proving it is safe and effective on live patients .
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