With the Pre-Marketing Notice (510k), if you wish, you’ll be able to enter one of the world’s largest markets, as well as use your FDA approval certificate for your product, to outperform or match the competition in your country.
Our service includes
We will identify the classification, code and regulatory number of your product; possible devices to be compared (Predicate devices); and all the tests required for your application.
We may recommend laboratories and suppliers that, in our experience, do efficient and less expensive costs.
We review the results of the studies, to ensure they meet FDA-recognized expectations and standards
We will prepare all necessary documentation, develop the 21 sections comprising the 510k application and introduce it to the FDA, according to your standards.
Once the request has been received and accepted, we will follow up on the entire process and jointly respond to any additional questions or requests that the reviewer assigned to the case may have.
As an additional bonus to this service, we offer you, if you wish, the registration process, and the product listing with the FDA free of charge, for the first year. (The client will only pay the annual fee to the FDA)
Are you looking for more in-depth advice regarding 510k and our services?