Get the free K092967 - 510(k) Premarket Notification - FDA

December 7, 2018Global Scientific Technologies, LLC William Griswold, Jr. President P.O Box 1347 Duncan, South Carolina 293341347 Re:K180679 Trade/Device Name: CitriCon Liquid and Powder (Acid Concentrate

How to fill out k092967 - 510k premarket

How to fill out k092967 - 510k premarket

1. Obtain the K092967 form from the FDA website or relevant regulatory authority.
2. Carefully read the instructions provided with the form to understand the requirements.
3. Gather all necessary documentation, including device description, intended use, and indications for use.
4. Provide data from non-clinical and clinical studies that support the safety and effectiveness of the device.
5. Compose a comparison table that outlines how your device is similar to the predicate device.
6. Complete the sections of the form, ensuring all information is accurate and complete.
7. Review the entire application for any missing information or errors.
8. Submit the completed form and documentation to the FDA along with the required fee.

Who needs k092967 - 510k premarket?

1. Manufacturers of medical devices that are seeking market clearance in the United States.
2. Companies looking to market a device that is substantially equivalent to an already legally marketed device.
3. Entrepreneurs and startups developing new medical devices that require FDA approval.

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What is k092967 - 510k premarket?

k092967 is a specific 510(k) premarket submission to the U.S. Food and Drug Administration (FDA) that demonstrates that a medical device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file k092967 - 510k premarket?

Manufacturers of medical devices intending to market their product in the United States are required to file a 510(k) premarket submission, including k092967, if the device is not exempt from 510(k) requirements.

How to fill out k092967 - 510k premarket?

To fill out a k092967 - 510(k) premarket submission, a manufacturer must provide detailed information about the device, including its description, intended use, labeling, and substantial equivalence to a predicate device. Specific FDA guidance documents should be followed for proper formatting and content.

What is the purpose of k092967 - 510k premarket?

The purpose of k092967 - 510(k) premarket submission is to demonstrate to the FDA that the device is safe and effective for its intended use and is substantially equivalent to an existing legally marketed device.

What information must be reported on k092967 - 510k premarket?

The k092967 - 510(k) premarket submission must report information such as device description, intended use, manufacturing processes, performance testing results, labeling information, and comparisons to predicate devices.