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510(k)

Home / Food & Drug Administration / 510(k)

Our team of PhD chemists is ready to help you in the testing and submission of your 510(k), as well as answering the following questions about your device from the FDA’s guidance document.

  • Do the devices have the same technological characteristics?
  • Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
  • Are the methods acceptable?
  • Does the data demonstrate substantial equivalence?

Here are our latest case studies, white papers and other 510(k) information.

Related Standards

1663 1664 510(k) 661 665 EN 1186 EN 1186-2 EN 1186-3 EU 10-2011 EU No 10/2011 FDA 176.170 FDA 177.1380 FDA 177.1810 ICH Q3D ISO 10993

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