Grapefruit USA Inc (GPFT)

[marysawa92]

<<Assyria_Will_Rise - No this is not correct. Nothing is 100% especially not with the FDA. They aren't held accountable to any deadlines on a 510K submission. They have guidelines, but not deadlines. 150 days comes into play and statistically 98% of the submissions receive an answer.

90% of 510(k)s in 90 days
98% of 510(k)s in 150 days

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109319.htm