Replies to post #4541 on Grapefruit USA Inc (GPFT)

[mx10001]

In the last conference call, Dean stated that he would be very happy (obviosly so would most of us) if approval came before or even during RSNA. RSNA begins on November 29th and runs through December 4th, so that is betwenn 20 and 24 days. The last submission was handled in that amount of time, and with the back and forth between Dean and the FDA on this topic already, I am confident that Dean knows what is acceptable to the FDA. Further uses can be applied for later. No need to push for contraversial uses. Right now, Dean has his eyes on approval for RSNA and, IMO, he will get it.

[goldcoastoh]

fda video on 510k submission tracking decision... toward the end of the video they tell you what the clearance/approval letter is all about - why/how it's mailed etc. etc...

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

scroll down to fda's "log-in procedure" and watch...