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Homer Simpson

09/19/11 8:36 PM

#47381 RE: adrian taylor #47380

You could call it a collision course with the FDA. It will happen soon and the DViS will be approved. The DViS goes into production and Dean takes all the bag holders to the top!

I will write the book "The DViS and its collision course with the FDA" Great idea.
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FormerMarine

09/19/11 11:55 PM

#47388 RE: adrian taylor #47380

Adrian, isn't it true that the FDA seeks only to prove substantial equivalence in a 510k application vs judging the surgical quality of pictures?