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Phil Packer

05/24/11 3:23 PM

#43661 RE: Dr. Mugs #43660

You have proof? I would say negative!!!!

exium

05/24/11 3:27 PM

#43663 RE: Dr. Mugs #43660

Dean Janes tried to "con" the FDA and the FDA saw right through all of his lies and REJECTED what he was trying to peddle. Dean Janes submitted a 510K for a device that was no where near the final stages of development. This is an illegal act in and of itself!! The FDA has thrown his crappy non-working scam of a device into class 3. This device will never, ever be approved by any means!!!



There were no cons. He gave them what they were asking for "before". Remember Dean has successfully submitted 510k in the past. In light of the new FDA regulations, Dean had to get outside help. Not to mention the change in the FDA panel that the company had to undergo. I am sure like you, Dean is just AS frustrated.