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OldYankee

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OldYankee

Re: boston745 post# 7023

Monday, 09/26/2016 6:19:36 PM

Monday, September 26, 2016 6:19:36 PM

Post# of 41611
I read that as well which further convinced me that SE has not been determined yet. Also, see FDA's "Appendix A. 510(K) Decision-Making Flowchart" (sorry, I couldn't figure out how to upload it to this post).
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