510(k) Forms

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Forms associated with Premarket Notification (510[k]) submissions

• Acceptance Checklists for Traditional, Abbreviated, and Special 510(k)s
• Premarket Notification Class III Certification and Summary
• Premarket Notification Truthful And Accurate Statement
• Premarket Notification 510(k) Statement
• Exempt Device Review Form (PDF - 16KB)
• 510(k) Cover Sheet Memorandum (PDF - 41KB)
• 510(k) "Substantial Equivalence" Decision Making Process (PDF - 844KB)
• Indications for Use (PDF - 1.7MB)
• Required Elements for a Declaration of Conformity to a Recognized Standard

Content current as of:

Regulated Product(s)

• Medical Devices
• Radiation-Emitting Products