Question: Should Premarket Notification [510(k] applicants include the Acceptance Checklist for Traditional, Acceptance Checklist for Abbreviated 510(k) s, and Acceptance Checklist for Special 510(k)s in a

Should Premarket Notification [510(k] applicants include the Acceptance Checklist for Traditional, Acceptance Checklist for Abbreviated 510(k) s, and Acceptance Checklist for Special 510(k)s in a 510 (k) submission based on the type of submission? Please refer to FDA guidance document entitled "Refuse to Accept Policy for 510(k)s " document issued on September 13, 2019

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