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askjsell

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askjsell

Re: Erbb post# 64469

Sunday, 11/29/2015 3:29:24 PM

Sunday, November 29, 2015 3:29:24 PM

Post# of 330393
Sure,

Here is the link:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

This clearly states the FDA will communicate the status of a 510k application at 100 days.
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