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Friday, November 24, 2017 7:04:13 PM
There is really no road blocks to submit to the fda when submitting a 510k. It's not like a drug. Many products get 510k approval without much difficulty.
With this product the main driver to share increase is if it actually will be bought by hospitals. And the driver of that is cost and physician interest, and the belief that the hospital can gain market share with the newest and best tech.
Next month hope to see the product in person and reassure my confidence in this investment.
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