Grapefruit USA Inc (GPFT)

[AndersunGraphics]

From: [e-mail]
To: xxxxxxxxxxxxxxx CC: [e-mail]
Date: Fri, 25 Feb 2011 16:29:49 -0500
Subject: 02-589 eje CDRA Devices

Dear XXXXXXXXXXXX,


Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.


Question:
Does this mean that the FDA has cleared this product for marketing?

Thanks