Medizone Intl. (fka MZEIQ)

[Eli's Gone]

2. 513(g) submission made on May 17, 2017
• Expected response within 60 days
• Highlights from the submission:
• Request for “confirmation that the company’s AsepticSure®
(“AsepticSure® System” or the “system”) is not considered a medical
device when used for general hospital disinfection purposes, and in
addition, is exempt from premarket notification requirements.”
• Rationale for exemption: “Several devices which have been listed with
FDA (class I device with pre-market exemptions) make virtually the
same claims as the AsepticSure® system.”
3. Hogan Lovells US LLP is leading the communications with the FDA