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Re: JKM1 post# 6796

Friday, 08/11/2017 2:44:43 PM

Friday, August 11, 2017 2:44:43 PM

Post# of 10345
You are right
I read the steps again on fda site -

"..Within 15 days of the receipt of the submission, the submitter will receive an electronic notification of the Acceptance Review result, ..."

Based on this - the acceptance review decision timeline has passed. This means company must have already received the mail.

While I am not expecting anything from con- a PR confirming move to next step will support the SP


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