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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Heather Bell President 12125 Woodcrest Executive Dr. Ste. 320 St. Louis MO 63141 Re K143332 Trade/Device Name FAST Sphyg by Koven Regulation Number 21 CFR 870. 1120 Regulatory Class Class II Product Code DXQ Dated February 25 2015 Received March 3 2015 Dear Ms. 1120 DXQ Substantial Equivalency The FAST Sphyg by Koven is...
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How to fill out 510k premarket notification
How to fill out 510k premarket notification
01
Step 1: Gather all necessary information and documents required for the 510k premarket notification.
02
Step 2: Fill out the coversheet by providing the appropriate contact information and device details.
03
Step 3: Prepare a detailed description of the device, including its intended use, design specifications, and manufacturing process.
04
Step 4: Conduct a risk analysis and provide supporting documentation.
05
Step 5: Include labeling information, such as instructions for use, warnings, and precautions.
06
Step 6: Prepare a substantial equivalence analysis comparing the device to a legally marketed predicate device.
07
Step 7: Compile and submit the completed 510k premarket notification to the U.S. Food and Drug Administration (FDA).
08
Step 8: Pay the required user fee.
09
Step 9: Respond promptly to any additional information or requests for clarification from the FDA.
10
Step 10: Await the FDA's decision on the 510k premarket notification.
Who needs 510k premarket notification?
01
Medical device manufacturers who plan to market a new medical device in the United States.
02
Manufacturers seeking to make significant modifications to an existing medical device already on the market.
03
Companies importing medical devices into the United States for the purpose of commercial distribution.
04
Distributors and third-party organizations who intend to commercially distribute a medical device in the U.S.
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