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Re: None

Wednesday, 06/02/2021 11:19:16 AM

Wednesday, June 02, 2021 11:19:16 AM

Post# of 31293
Forms don't cause 6 year FDA delays. Bad products and bad management do.

There is something critically flawed with the product and the management to have spent hundreds of thousands of dollars and touted imminent FDA clearance over six years and still no FDA cleared product.

Anyone who believes hiring a third party to file some forms is going to solve those issues and pop out an FDA 510k in a few months is living in the bottom depths of delusion.
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