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jtsmgoblue

08/07/18 11:41 AM

#8573 RE: Amatuer17 #8571

“The odd thing is - the sensitization trial will conclude in Q3-2018 and 501K will be submitted in Q3-2018 - that is too fast for any company much less for Arch - time will tell “

What do you know about submitting 510k filing or frankly any mgmt report update?

The boiler plate 510K is and has been complete. It’s a refile with the supplemental supportive data. Should be plug and play. For any company this is SOP. That’s the difference between amateurs acting as professionals and real professionals

Of course all assumes positive skin sensitivity data.