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goldcoastoh

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goldcoastoh

Re: Ryoko post# 4541

Monday, 11/09/2009 8:49:50 PM

Monday, November 09, 2009 8:49:50 PM

Post# of 59550
fda video on 510k submission tracking decision... toward the end of the video they tell you what the clearance/approval letter is all about - why/how it's mailed etc. etc...

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

scroll down to fda's "log-in procedure" and watch...
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