Medizone Intl. (fka MZEIQ)

[Eli's Gone]

While they have certainly missed the entire side of the barn on this since 2009---IMO FDA approval is a given (LOLOL) and hinges on EPA approval based on the bolded here:

We anticipate that the United States will become th
e third country approving the sale of AsepticSure®.
As expected by our
development and regulatory team, the United States
Food and Drug Administration (“FDA”) has ruled that
AsepticSure®
is a Class I medical
device (Code LRJ, Class I Disinfectant, Medical Dev
ices; covered under 880.6890 General Purpose Disinf
ectants). This is the lowest and safest
medical device class. According to FDA 21 CFR Parts
862-892, the technology is exempted from pre-
market authorization, so FDA approval
need only be sought when the technology is mature,
validated and MARKET-READY.

without the EPA stamp, the device is not "market ready" in the U.S.A IMO