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Re: toohot post# 143935

Tuesday, 06/26/2018 9:47:29 AM

Tuesday, June 26, 2018 9:47:29 AM

Post# of 330302
I hope it goes down like that, toohot. The post op one, I don't know that they are going to file a 510k right away. They are doing the FDA Challenge and they are taking applications till the end of September.

This was a reply from Paul K.- Has the 510k for post-surgical use been submitted? No it will most likely be submitted into the FDA’s opioid mitigation program.

Does that mean it wont be submitted till Sept or Oct? IDK. I will try to get clarification from him.