Lets be clear, I've never said it would take 3 to 4 months, I've actually said the last FDA 510k took me between 5 to 6 months and that it was a possibility. Also We DO have FDA approval!!! If they were going to deny the application they would never let me distribute it period! Also there is no grand conspiracy, GE and the other big boys have no effect on the FDA and what they decide, may I remind you GE got shut down by the FDA for almost two years!
June 15th will be a year and yes this is longer than I expected. But as I've always said, it is completely out of my hands. The FDA has recently shifted to a electronic format, which is causing some issues as they haven't perfected it. The SEC's EDGAR system, I'm told, had the same problems.
Dean
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