TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:RE:RE:RE:RE:job offer

[elgin1]

BernardBaruch60 wrote:

Marilyn, "So aren't they saying that if the scope (endo or duodenoscope) falls within the dimensions then it can be sterilized? Doesn't this just come down to getting IFU's from OEM's?"

No.  Getting IFU's from OEM's has nothing to do with FDA Clearance.  The dimensions being the same or similar to duodenoscopes does not give it FDA Clearance.  Matter of fact, it specifically shows the FDA may had reason NOT to give it clearance.  

The fact everyone on here believed we had FDA Clearance for a Duodenoscope, when we never had such a clearance is the point I'm trying to make!

I bought the stock going off what I read on the TSO3 website and in their literature.  Only after going through the entire 510k did I see where we had no such clearance whatsoever.

Bothersome when you add this to a whole list of other issues.
 

Funny you bring this up today when there is news. They have clearance for the demensions listed.  So if you have a scope (dudenoscope) that falls in the demensions it can be sterilized. 

Go back to selling your obselete ETO sterilizers Bernie or better yet go find Burt @ Sesame street.