Get the free 510(k) Number K042676 - accessdata fda

NEC 1 7 N00 510(k) Summary of Safety and Effectiveness 12.0 This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. 510(k)

How to fill out 510k number k042676

How to fill out 510k number k042676?

1. Begin by gathering all the required documentation and information for the application process.
2. Review the instructions provided by the FDA for filling out the 510k application form.
3. Complete the contact information section, providing accurate details such as company name, address, and contact person.
4. Fill in the product information section, including the device name, intended use, and a brief description.
5. Provide the product code and classification information as per the FDA guidelines.
6. Include any necessary clinical data or studies that support the safety and effectiveness of the device.
7. Complete the labeling information section, ensuring all necessary labeling and packaging requirements are met.
8. Provide any additional information or documentation requested by the FDA in the appropriate sections.
9. Review the completed application thoroughly to ensure accuracy and completeness.
10. Submit the completed 510k application along with the required fees to the FDA for review and evaluation.

Who needs 510k number k042676?

1. Medical device manufacturers who intend to market and distribute a new medical device in the United States may require a 510k number.
2. Medical device distributors or importers who plan to commercialize a medical device that has not previously been cleared by the FDA may also need a 510k number.
3. Healthcare facilities or organizations that wish to purchase and use a medical device that is subject to the 510k requirements will need to ensure that the device has a valid 510k number.

For pdfFiller’s FAQs

What is 510k number k042676?

510k number k042676 is a unique identification number assigned by the U.S. Food and Drug Administration (FDA) to a medical device that has undergone a 510k premarket notification process.

Who is required to file 510k number k042676?

The medical device manufacturer or distributor is required to file 510k number k042676 with the FDA.

How to fill out 510k number k042676?

To fill out 510k number k042676, the medical device manufacturer or distributor needs to provide detailed information about the device, its intended use, design, materials, performance data, and comparisons to similar legally marketed devices.

What is the purpose of 510k number k042676?

The purpose of 510k number k042676 is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device and does not pose a significant risk to the public health.

What information must be reported on 510k number k042676?

The medical device manufacturer or distributor must report detailed information about the device's technical specifications, labeling, intended use, clinical data, and any potential risks or hazards associated with its use.

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