Monday, December 11, 2017 6:22:58 PM
That is why i like to post the actual data with my comments when i can, if someone does not like how i'm stating it then you can read the actual truth for yourself.
where is the foundation for clearance results based on "similar" and showing that Senhance results were not substantially equivalent to Davinci? ?
if Senhance were not equally as effective as Davinci during the FDA test track, it would not have been determined 'substantially equivalent'. it would have been determined 'non equivalent' or 'less than equivalent'. or one could even say 'similar'. Similar and equivalent are two vastly different determinations.
Some of these FDA reports use big words and complex, overly specific phrasing, but it is still English.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm580452.htm
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