510(k) Medical Device Premarket notification submissions

Welcome to our 510(k) submissions- simplified website. It is an efficient electronic platform allowing the simplification of defining and transmitting of the required information. You would fill out and upload your medical device information in an organized manner. We will walk you through the process and help you narrow down all the needed information.

Our website links to FDA databases - which will be reflected within the screens as you fill out certain information. Please help us by providing good quality information.

We are one email or phone call away!

For security reasons, we screen users prior to providing access, typically completed within 24 hours. We appreciate your patience and understanding.

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