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.