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This sounds awesome

You mentioned that your process doesn't require a clean room. What are the regulations around getting a catheter "approved" for human use? Do you need to run some expensive trials or is this something that you can scoot around?

ie. If I wanted to use your catheters tomorrow, other than a repeatable manufacturing process whats stopping me from ordering a few thousand and putting them to use?

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We know that it does need FDA approval and trials. What we are hoping is that we can file what is known as a 510(k). A 510(k) is a process where we tell the FDA "Hey look at these guys, we are doing pretty much the same thing" and we can skip most of the hard and expensive part. We don't know yet if we can file a 510(k) or if we need to go through the whole process.

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