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EUA has expired…what next? Explanation of the 510K process

September 21 | 11:00 am - 12:00 pm

How to Adapt Your Culture to Support Your New Covid-19 Safety Practices

No one knows when it will happen, but eventually it will. Learn how to make sure your medical device can continue to be sold in the U.S. once the pandemic is over. In this webinar,

Darren Reeves, president of DP Distribution & Consulting, will discuss:

  • What will happen to my devices made during the pandemic but have not yet sold?
  • What must I do for any medical device to continue?
  • What must I do for class II medical devices (e.g., Surgical Masks, N95s and Surgical Gowns)
  • What is a 510(k)?
  • Steps to achieve a 510(k)?
  • How long does it take?
  • What does it cost?