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Zeppo

05/26/17 3:23 PM

#44647 RE: BenK #44646

I wasn't very familiar with the 510k regulation until it popped up with Medizone. I started reading a lot about it. I guess I could be wrong, but I get the impression that it's similar to the normal labeling issues that come with new drugs getting ready to hit the market......except it's for medical devices. Hey Elis.....what's your take on it?