Wow, the FDA is a bunch of idiots...maybe Dean is not lying after all? Oh wait, I forgot the device does not work in the first place. HAHAHAHAHAHA!!!!!
That's a tough one NAP. Its not like we have that info...especially since MWE is not on board and this also is not a review of the 510K only a meeting before they supposedly submit a brand new one David G Brown was the signed name on the NSE.