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Comment by BernardBaruch60on Jun 11, 2019 2:40pm

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Post# 29816072

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

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.