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Re: Chief Slapaho post# 64495

Tuesday, 05/16/2017 11:34:47 PM

Tuesday, May 16, 2017 11:34:47 PM

Post# of 173800
As I mentioned before it's not your typical device that you will create a prototype for it then produce it for commercial use. Basically it's two symbol syringes one for hydrogel and the other one for Y90. Fda won't take the responsibility to approve drug or device without adiquote data which wasn't provided in the first 2 submissions that's why Korenko was brought in to manage the process and protocol
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