The following content should be included in an abbreviated 510(k) submission:

• Cover sheet identifying the submission as an “Abbreviated 510(k)”
• Information required under 21 CFR 807.87, including:
  -    Description of device
  -    Intended use and indications for use
  -    Proposed labeling
• Summary report that describes guidance, including:
  -    How the guidance was used to demonstrate substantial equivalence
  -    How the device complies with special controls
  -    Device description
  -    Manufacturer’s device design requirements
  -    Risk management
  -    Test methods
• Voluntary Consensus Standards (if needed)
• Data and information to address issues not covered by guidance documents, special controls, and/or voluntary consensus standards
• Indications for Use form (FDA Form 3881)

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