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Re: None

Sunday, 05/13/2018 8:20:15 PM

Sunday, May 13, 2018 8:20:15 PM

Post# of 329221
Estimated 27 days to approval based expedited approval. Refer to link for FDA 510K time guidance.

Price will head towards at least a penny in next 27 Calendar days. GLTA!

Normal FDA 510K is projected to be completed in 90 calendar days.

Just based on the regular not expedited we have no more than 57 calendar days till approval worst case scenario.

Expedited I would estimate 27 days to approval would be my guess. Already day 3 let the countdown begin.


https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm408913.gif

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm