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June 28, 2018, Richard Wolf Medical Instruments Corporation Michael Loiter man US Head of Regulatory QA/QC 353 Corporate Woods Parkway Vernon Hills, IL 60061Re:K180583 Trade/Device Name: LOGIC 4K

How to fill out 003510k-summary

How to fill out 003510k-summary

1. To fill out the 003510k-summary, follow these steps:
2. Start by gathering all necessary information, such as the device name, manufacturer information, FDA registration number, and a brief description of the device.
3. Next, provide a detailed summary of the intended use of the device, including any indications for use and the target patient population.
4. Include a brief description of the device's design and principles of operation, highlighting any unique features or technologies.
5. Provide a summary of any performance testing or clinical studies conducted on the device, along with the results and conclusions.
6. Detail any potential risks associated with the device and any mitigations or safety measures implemented.
7. Lastly, ensure that all required forms and attachments are included, such as product labeling, labeling samples, and any applicable certifications or clearances.
8. By following these steps, you can successfully fill out the 003510k-summary for your medical device.

Who needs 003510k-summary?

1. The 003510k-summary is needed by medical device manufacturers who are submitting a premarket notification (510(k)) to the U.S. Food and Drug Administration (FDA).
2. This summary provides a concise overview of the device, its intended use, design features, performance testing, and potential risks or safety measures.
3. It is an essential part of the 510(k) submission and helps the FDA assess the device's safety and effectiveness compared to predicate devices.
4. Therefore, any medical device manufacturer seeking FDA clearance to market their device in the United States needs to include a properly filled out 003510k-summary.

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What is 003510k-summary?

003510k-summary is a summary report that provides information about a medical device submission under Section 510(k) of the Federal Food, Drug, and Cosmetic Act.

Who is required to file 003510k-summary?

Manufacturers or distributors of medical devices who have submitted a 510(k) premarket notification to the FDA are required to file 003510k-summary.

How to fill out 003510k-summary?

003510k-summary can be filled out online through the FDA's Electronic Submission Gateway (ESG) using specific forms and templates provided by the FDA.

What is the purpose of 003510k-summary?

The purpose of 003510k-summary is to provide a concise summary of the information contained in a 510(k) submission, including the device description, indications for use, and summary of test data.

What information must be reported on 003510k-summary?

Information such as device description, indications for use, summary of test data, and any changes made to the device or labeling must be reported on 003510k-summary.