RE: Email sent a few days ago3 Mar 2024 10:54
I’ve sent a few plus contact MW through LinkedIn but no response.
Need to know if the fda application is for class1 or 2.
When exactly was the de novo application submitted.
Have they been given a response date by fda or is it just an assumption. De novo process takes much longer than fda clearance.
What is the application number, we should be able to track it on the fda site, from what I have seen.