510(k) Forms

List of forms associated with Premarket Notification (510[k]) submissions

• 510(k) Pre-Review Form 
• Exempt Device Review Form 
• Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions 
• 510(k) Review Template 
• Premarket Notification [510(K)] Status Request & Response 
• 510(k) Review Template Instructions 
• 510(k) Cover Sheet Memorandum 
• 510(k) “Substantial Equivalence” Decision Making Process 
• Standards Data Form for Abbreviated 510(k)s 
• Sterile Devices in Premarket Notification [510(k)] Submissions 
• Description of 510(k) "Substantial Equivalence" Decision-Making Process (Accessible Text) 
• Premarket Notification Class III Certification and Summary 
• Premarket Notification Truthful And Accurate Statement 
• Premarket Notification 510(k) Statement 
• Required Elements for a Declaration of Conformity to a Recognized Standard