Replies to post #18191 on Grapefruit USA Inc (GPFT)

[IMGGorBust]

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm#link_6

Decision Letter Issued:

The decision letter will be mailed and faxed, if a fax number has been provided, to the submitter upon receipt of the completed 510(k) from the reviewing division. The Document Mail Center staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed.

[fink]

Your absolutly correct. Either way it will have to be given to Dean and then the shows on. I bet he is there every morning looking for the Fed Ex man.
I do think at this time IMGG and the FDA has built up a repour and a phone call is the way its going down.


To me its like waiting on a jury. The longer it takes means there are a few within fighting over their own concerns. A quick response would have been a slam dunk, thanks for the clearification, and here you go, Go make a bundle!!