We have successfully prepared, submitted and obtained FDA clearance for over 600 510(k)s since 1978. Not only will we work closely with you staff in providing a understanding of what is required for the 510(k) submission but we will assist with outlining a strategy in getting 510(k)s for devices for which it may be hard to show substantial equivalency. We work closely with the FDA Office of Device Evaluation from the beginning of the project to assure the most rapid review possible. Our track record of getting FDA clearance for clients is unmatched.