https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-premarket-notification-submissions-510ks
User Fees and Refunds for Premarket Notification Submissions (510(k)s) | FDA
This guidance identifies the types of 510(k)s subject to user fees, exceptions to user fees, and the actions that may result in user fee refunds.
fees and refundsuserpremarketnotificationsubmissions