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Re: Amatuer17 post# 6737

Tuesday, 08/01/2017 10:37:26 AM

Tuesday, August 01, 2017 10:37:26 AM

Post# of 10345
I believe the Acceptance Review should be completed 15 calendar days from the date of the submission (July 17). That is today!

See www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm