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[Music] hi everybody this is Joe Hage I have the privilege of leading your medical devices group which as of this recording has three hundred fifty four thousand members worldwide but weve moved off LinkedIn we now live at medical devices group net where we have plenty of great functionality and were building even more I look forward to your suggestions todays guest host you know Im you love them Robert Packard he is gonna teach us today about how to prepare a medical device 510k submission for the FDA I will put myself on mute its Roberts show were just living in it Rob take it away thank you Joe todays presentation I realized when I started updating slides that there is no possible way for me to include everything you need to know in a 510 K in one of these slide decks I might have tried a couple of years ago but now Im not even gonna bother what I am going to try to do is try to give you pointers to the latest updates that you might not be aware of and almost everything in t