Medizone Intl. (fka MZEIQ)

[Eli's Gone]

Seems fairly straight foreword---did I just say that pertaining to this company and it's regulatory "journey"-please slap me LOL

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm

510(k) exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered "510(k) exempt." These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness.

These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

be suitable for their intended use
be adequately packaged and properly labeled
have establishment registration and device listing forms on file with FDA
be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)