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Simpsonly

08/29/14 6:40 PM

#42275 RE: seven-up #42273

C'mon 7up, are you telling me that Jimzin is actually James Eason of Covington 'Yamayama' Vodka, the best yam vodka in the world and he's a BIEL shareholder? That guy is totally famous and the vodka is sometimes hard to get because it's often sold out due to it's popularity. Couldn't even order it from covingtonvodka.com, I have to order it ahead of when my guy gets a few bottles. It's far better than Grey Goose! Wow, wonders never cease, Jimzin is Eason of Covington Vodka, who would've known.

StockinUp

09/02/14 12:52 PM

#42329 RE: seven-up #42273

This tells me that the comments posted by credible sources, such as doctors, and those from test subjects and trial users saying "This device not only reduced or eliminated my psin, it also cause no possible side effects" will be used by the FDA to eliminate the need for special controls and satisfy any potential risk with general controls (labeling).

We know from the FDA documentation that they look for an UNREASONABLE risk, and our risk is 1 or 2 on a scale of 10. We are heading to Class I. I can feel it.

The FDA, from their own documentation, told us that they are required to place it in the lowest class possible and it qualifies as a Class I. There is no denying that from a reasonable, sensicle, and logical perspective.

The FDA will review and consider comments made in response to the issuance of the proposed order. The FDA will also consider changes to the proposed classification (and special controls for Class II devices) based on its review of the comments