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.