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510(k) SubmissioLr3MP Color LCD Display46510(k) Summary FEB 1 4 2014 As required by 21 CFR 807.92 1. Date Prepared 21 CFR8O7.92 (a) (1) December 24, 20132. Submitter's Information 21 0FR807.92 (a)

How to fill out 510k submissiolr

How to fill out 510k submissiolr

1. To fill out a 510k submission, follow these steps:
2. Begin by gathering all relevant information and documentation about your medical device.
3. Complete the FDA's 510k submission form, providing accurate and detailed information about the device.
4. Include any necessary clinical data, testing results, and performance information to support the safety and efficacy of the device.
5. Make sure to include a thorough description of the device's intended use, indications for use, and any special features or technologies it utilizes.
6. Prepare a comprehensive summary of any similar devices already cleared by the FDA and explain how your device is different or improved.
7. Compile all the required supporting documents, such as labeling, manufacturing information, and risk assessments.
8. Review your submission carefully to ensure all information is accurate and complete.
9. Submit the 510k submission to the FDA electronically through the FDA's online portal or by mail.
10. Follow up and respond promptly to any communication or requests for additional information from the FDA.
11. Await feedback and clearance from the FDA before marketing or distributing the medical device.

Who needs 510k submissiolr?

1. The following entities or individuals may need to submit a 510k submission:
2. - Manufacturers of new medical devices that are not exempt from the FDA's premarket notification requirements
3. - Manufacturers of modified or substantially equivalent medical devices
4. - Companies or individuals seeking FDA clearance to market and distribute a medical device in the United States
5. - Importers of medical devices into the United States
6. - Distributors or retailers of medical devices in the United States
7. - Healthcare facilities or practitioners involved in the use or implantation of medical devices

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What is 510k submission?

510k submission is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.

Who is required to file 510k submission?

Manufacturers of medical devices seeking marketing clearance in the United States are required to file a 510k submission.

How to fill out 510k submission?

To fill out a 510k submission, manufacturers need to provide information on the device, comparisons to similar legally marketed devices, and data demonstrating the safety and effectiveness of the device.

What is the purpose of 510k submission?

The purpose of 510k submission is to demonstrate the safety and effectiveness of a medical device before it is marketed in the United States.

What information must be reported on 510k submission?

Information on the device description, intended use, technological characteristics, device performance testing, and labeling must be reported on a 510k submission.