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510(k) Submission 3MP Color LCD 510(k) Summary (As required by 21 CFR 807.92 FEB 1 4 2014 1. Date Prepared 21 CFR8O7.92 (a) (1) December 24, 2013 2. Submitter's Information 21 CFR8O7.92 (a) (1) Name

How to fill out 510k submisso - accessdata

How to fill out 510k submission - Accessdata:

1. Gather all necessary information and supporting documentation required for the submission. This can include product labeling, performance testing data, clinical studies, and any other relevant documentation.
2. Begin the submission process by creating an account on the Accessdata website. This will allow you to access the necessary forms and tools for submitting your 510k application.
3. Once you have logged in to your account, select the option to start a new 510k submission. Follow the prompts and provide all requested information, such as your contact details, device description, and proposed use.
4. Upload all required documents and supporting evidence in the appropriate sections of the submission form. This may include product specifications, design drawings, and risk assessments.
5. Review your submission carefully to ensure all information is accurate and complete. Double-check that all required documents and supporting evidence have been uploaded correctly.
6. Pay the required submission fee, which can be done online through the Accessdata website. Keep records of your payment confirmation for future reference.
7. Submit your completed 510k submission. Once submitted, you will receive a confirmation email or notification that your submission has been received.

Who needs 510k submission - Accessdata:

1. Medical device manufacturers who are introducing a new device to the market or making significant modifications to an existing device may need to submit a 510k application to Accessdata.
2. Companies that wish to obtain clearance from the U.S. Food and Drug Administration (FDA) to market their medical device in the United States will need to complete the 510k submission process.
3. Medical device distributors, importers, or anyone involved in the supply chain of medical devices should be familiar with the 510k submission process and requirements, as they may be responsible for ensuring that the devices they handle have proper FDA clearance.

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What is 510k submission - accessdata?

510k submission is a premarket notification submitted to the US 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 (predicate device).

Who is required to file 510k submission - accessdata?

Medical device manufacturers who intend to market a new device in the United States are required to file a 510k submission with the FDA.

How to fill out 510k submission - accessdata?

To fill out a 510k submission, manufacturers need to provide detailed information about the device, including a description of the device, its intended use, comparison to a predicate device, and any clinical data or testing conducted.

What is the purpose of 510k submission - accessdata?

The purpose of a 510k submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed device and is therefore safe and effective for its intended use.

What information must be reported on 510k submission - accessdata?

Information that must be reported on a 510k submission includes device description, intended use, comparison to a predicate device, performance data, and labeling information.