Medizone Intl. (fka MZEIQ)

[Eli's Gone]

As expected by our development and regulatory team, the United StatesFood and Drug Administration (“FDA”) has ruled that
AsepticSure® is a Class I medical
device (Code LRJ, Class I Disinfectant, Medical Devices; covered under 880.6890 General Purpose Disinfectants). 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6890