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flare9x

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flare9x

Re: $heff post# 79448

Monday, 03/31/2014 11:19:43 AM

Monday, March 31, 2014 11:19:43 AM

Post# of 97239
APPY..2.63 - FDA aims to send final decision on the 510k (usually by day 90) By day 90 will take us to the end of June 2014.

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