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
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