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Regis999

08/03/16 1:13 PM

#3323 RE: 21money21 #3314

So you do not need human trials results to obtain CE Mark. Companies have obtained CE Mark in less than two months without human trials.

I discussed this point with Company. They could have gotten CE Mark years ago but it would mean nothing without human trials. No doctor would use product without human trials.

I wonder if they are not trying to get both at the same time.
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JUST 10-11-12

08/03/16 1:29 PM

#3327 RE: 21money21 #3314

well, the rep I spoke with from the company"

1)either is lying
2)they are doing both
3)they are working on the trial data and submitted an application.

hoping for number three. I guess, two and three are the same.

However, like one poster put, if they have the data, it either takes time to sort out and publish, or they are trying to get the CE Mark with what they have in hand.

just all speculation...but some based on the feedback of the rep.

take care. Keith