Grapefruit USA Inc (GPFT)

[BuyOnDips]

AT and Mugs

Did you happen to read this portion of the response from the FDA in the email I posted? Let me put it in bold for you.

KF



This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.