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Re: pix post# 140964

Thursday, 06/07/2018 8:15:39 AM

Thursday, June 07, 2018 8:15:39 AM

Post# of 335383
The way the 510K process works they submit it usually two weeks later FDA sets up a pre submission meeting to provide guidance on your 510K you submitted. If they are good with the 510K they approve the submission. So for both cases they already filed the 510K and they are being expedited.
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