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Ann Arbor Spark

How do I get a 510(k)? – Part 1 of 4 on MedTech Crossroads

Friday, October 29 2021 at 2:00pm - 3:00pm

Recently, we were taken up short by the simplicity of a question we received… “how do I get a 510(k) from FDA?”

For the next four weeks leading up to Thanksgiving break, we’re going to step through this important and fundamental question from square one. We’ll cover:

Friday October 29th – “How do I know if a 510(k) is right for me?”
Friday November 5th – “What goes into a 510(k)?”
Friday November 12th – “How do I prepare for a 510(k)?”
Friday November 19th – “What happens after I file?”

For everyone engaged in the process of developing a medical device, this series within a series is not to be missed. Your questions are welcome, and we’ll field them throughout! This event is sponsored by in2being.