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Amatuer17

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Amatuer17

Re: Amatuer17 post# 6724

Tuesday, 08/01/2017 8:45:48 AM

Tuesday, August 01, 2017 8:45:48 AM

Post# of 10345
510k application steps

Submitted - 17th July

Acknowledgement received - 25th Jul (within 7 days as per guideline)

8th Aug - Acceptance review result

This is key as the 1st committee goes through full checklist and gives acceptance decision (acceptance - or not acceptance and put on hold)

Not sure company will issue PR for this step but if they are put on hold or rejected - it is a material event so company will have to issue PR

So we can see some signs by Aug 10-11 - a PR.

The process is quite quick
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