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Re: None

Wednesday, 06/27/2018 11:47:22 AM

Wednesday, June 27, 2018 11:47:22 AM

Post# of 330301
Hopefully 2 days till the General clearance 510k gets submitted and clearance 30 days after. I'm trying to nail down the when they plan on filing the 510Ks for post surgical use and Allay.

This is from Paul K.
We are planning to submit both the 510(k) for post operative pain and an application to participate in the FDA's Innovation Challenge. The participation in the Innovation Challenge presents the opportunity to get an indication of use to mitigate opioid use.

We do not have a schedule yet for the Allay product.