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Re: ahab333 post# 5837

Thursday, 03/16/2017 1:38:13 PM

Thursday, March 16, 2017 1:38:13 PM

Post# of 10345
My conjecture and summary from postings here. I'm sharing my opinion based on limited information and trying to make sense out of the reality of some line items still pending.


I read the following and paraphrased it as a paperwork/processing issue that may have been filed incorrectly keeping the manufacturer from obtaining a required certification or other requirement ...

that PRIOR to filing the manufacturer was processing it as a drug not a medical device. It is signigicantly different so this caused the delay