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veni vidi vici

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veni vidi vici

Re: None

Saturday, 06/17/2017 10:32:59 AM

Saturday, June 17, 2017 10:32:59 AM

Post# of 59549
Looks like the company replaced its regulatory consulting firm a few days ago. Switching from Biologics Consulting to Med-Device Consulting seems like a big step down. As far as I can tell, Med-Device Consulting is a small local outfit run by a regulatory consultant named Louie Goryoka.

Here is a link to one of his successful FDA 510(k) applications from last year:
https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152168.pdf
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