Compliance 4 Devices
510k Service
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
Research
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.
Consulting
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
Preparation
We will prepare all necessary documentation, develop the 21 sections comprising the 510k application and introduce it to the FDA, according to your standards.
Support
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.
Company registration
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)
Carlos Marín
Consultant
Juan Tezak
Consultant
Are you looking for more in-depth advice regarding 510k and our services?
Contacts
- 118 W Prive Circle
Delray Beach, Florida 33445
USA. - +1 561 789 2411
- +1 561 789 2411
- compliance4devices@gmail.com
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Compliance 4 Devices
510k Consultants