When you think “510k” but FDA says “DeNovo” with Spencer Jones
![When you think “510k” but FDA says “DeNovo” with Spencer Jones](https://d3wo5wojvuv7l.cloudfront.net/t_square_limited_480/images.spreaker.com/original/092ac98ebb1fbccf0595e685f8581e5b.jpg)
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Description
What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones...
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Author | Monir El Azzouzi |
Organization | Monir El Azzouzi |
Website | - |
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