Hello fellow Rappers,
I am looking to do my first bundle 510k. I've read the guidance document, however I was hoping for more so here I am.
For anyone that's done a Bundle 510k, or has experience with them, can you tell me some pros/cons, pitfalls, and mistakes to watch out for?
We believe our devices fall under a "System" We have a monitor, cord, handles, electrodes, and inserts (scissors, graspers, dissectors etc.) the electrodes and inserts come either reusable or disposable. None of the devices can function on their own, they have to be connected to the monitor via the cord and handle to fulfill the intended use. Would you agree this meets the definition of a "System"?
If you were successful, I'd be interested in what format you used in your submission.
Thank you
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Kathaleen DeBarris, RAC
RAQA Analyst
Boulder CO
United States
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