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Re: mr_sano post# 38645

Monday, 03/07/2011 11:32:57 AM

Monday, March 07, 2011 11:32:57 AM

Post# of 59551
Sano, Apparently some people do not understand what an NDA is and why it is used. You say the jig is up. What makes you say that? I don't see anything proving the jig is up. All the talk that the DViS does not work is heresay. Just let this play out. Nobody has a definate answer except those that signed a NDA and they cant tell us.

As a reminder, if you missed the post earlier today as well as weeks ago, the FDA replied (in this post):

Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.

You can have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”



Keeping it real.
Homer