Medifirst Solutions Inc. (fka MFST)

[Tool_power]

Read up on the what "Substantially Equivalent" and "Pre-Market Release" mean. You're treating the MFST device as though it's a totally brand new novel device. It's not, it's just better than other similar devices on the market.

Further, they initially filed the 510(K) on August 28, 2015. The FDA provided a full review then and asked for more data/information. MFST conducted more clinical trials/experiments and provided the supplemental data June 26, 2016. The FDA had already reviewed the bulk of the 510(K) filing so it really just had to focus on the supplemental data. They made their decision on 7/8/2016 that the device is Substantially Equivalent to another device that is already approved for the market.

That's it! End of story! It can be sold in the US now.