Grapefruit USA Inc (GPFT)

[Dr. Mugs]

KKguru...I do not believe that Dean told us everything in the NSE letter. But the NSE decision makes the Dvis a class 3 device. In the NSE letter the FDA should had offered Dean the DeNovo path out of class 3 and back to class 2. I don't feel that path was offered so the only other option will be to file a brand new 510K with new supporting performance info by way of IDE.