Replies to post #44242 on Medizone Intl. (fka MZEIQ)

[Eli's Gone]

Need to get an answer as to whether the device is solely under EPA jurisdiction as DE indicated---or if the FDA needs to classify the device....

hope they don't spend a lot of time haggling over that point---if the FDA is involved, get an answer on whether the device is Class I exempt and lets go...if a premarket 510(k) is needed, file the darn thing, and hopefully it will be ruled substantially equivalent within 90 days and we go..

[futurist7]

Bolted, yes, with loot in tow.