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Wednesday, July 21, 2010 9:20:54 AM
"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!"
"No the FDA approval is a pass or fail and you will only be informed whether or not a device is approved or not. If a device isn't approved the process can continue until they are satisfied the device is safe & effective and follows Federal Guidelines."
So I would think Dean would be obligated to tell us that the FDA "denied" the submission. I think the clock is still running (it did not restart) but clearly no one knows when we will get the word. I like that Dean says "We DO have FDA approval!!! If they were going to deny the application they would never let me distribute it period!"
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