What information should be included in the 510(k) Cover Letter, 510(k) Summary, and 510(k) Statement?

The 510(k) cover letter should include information such as…

• Type of 510(k) submission
• Device type in plain terms
• 510(k) submitter name
• Contact information
• Recommended classification
• Device class
• Review panel
• FDA product code
• Preference for confidentiality

The 510(k) summary is similar, in that it is a brief summary of the device and the supporting information, while the 510(k) statement is a certification that the 510(k) holder will provide a copy of the submission to any FDA personnel within 30 days of a written request.

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