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Premarket
Notification 510(k)

Do you need advice on whether your organization requires an FDA Premarket Notification or how to prepare and submit your Premarket Notification 510(k) to the FDA if required?

Contact OnemataDC
for a free initial consultation today!

OnemataDC’s team is well-versed in the FDA’s thick and confusing pre-market approval process.  Our years of experience with hundreds of successful 510(k) submissions and approvals can support the launch of your new product.

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Our team has a 100% success rate across hundreds of submissions!


Lean on OnemataDC to identify the proper predicate device or product that will help fast-track your organization’s 510(k) submission gaining pre-market approval quickly.

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