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CCOVIDIEN 510(k) Sumnmary3 1Date summary prepared 21September2012 510(k) Submitter/Holder Civilian LIC 6135 Gun barrel Avenue Boulder, CO.80301 Contact Ted Kuhn Sr. Regulatory Affairs Product Specialist Office:

How to fill out 510k submitterholder

How to fill out 510k submitterholder:

1. Gather all the necessary information and documentation required for the 510k submission process.
2. Download the 510k submitterholder form from the official FDA website or obtain it from your regulatory consultant.
3. Fill out the submitterholder section accurately, providing your contact information, including name, address, phone number, and email address.
4. Ensure that you accurately specify your role in the submission process, whether you are the primary submitter or a co-submitter.
5. Double-check all the information you have entered to ensure its accuracy and completeness.
6. Sign and date the 510k submitterholder form, indicating your acceptance of the responsibilities associated with being the submitterholder.
7. Keep a copy of the completed form for your records.
8. Submit the completed and signed form according to the FDA's submission guidelines.

Who needs 510k submitterholder?

1. Medical device manufacturers who are planning to submit a 510k application to the FDA.
2. Regulatory consultants and experts who assist medical device manufacturers in the submission process.
3. Distributors or importers who act as the primary submitter on behalf of the manufacturer.

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What is 510k submitterholder?

510k submitterholder is the individual or company responsible for submitting a 510k premarket notification to the FDA for a medical device.

Who is required to file 510k submitterholder?

Any individual or company seeking to market a new medical device in the United States.

How to fill out 510k submitterholder?

To fill out a 510k submitterholder, the submitterholder must gather all necessary information about the medical device, conduct any required testing, and prepare a detailed submission to the FDA.

What is the purpose of 510k submitterholder?

The purpose of a 510k submitterholder is to demonstrate that the medical device is substantially equivalent to a device already on the market and is therefore safe and effective for use.

What information must be reported on 510k submitterholder?

Information that must be reported on a 510k submitterholder includes a description of the device, its intended use, its technological characteristics, and any clinical testing data.