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510(k) Summary K(101907 Date Prepared: November 22, 2010, Submitter: Harmonics Corporation 400 Wood Road. DC321 DC 321 Braintree MA 02184 Contact: Greg Calder Regulatory Affairs Specialist Phone:

How to fill out 510k summary k101907 22

How to fill out 510k summary k101907 22

1. Review the relevant regulations and guidance documents provided by the FDA.
2. Understand the purpose and requirements of the 510(k) summary.
3. Obtain the necessary information and documentation for the product being submitted.
4. Create a cover letter that includes essential details such as the product name, manufacturer information, and intended use.
5. Prepare a table of contents for the 510(k) summary.
6. Write an introduction explaining the purpose of the summary and providing an overview of the product.
7. Include a description of the device, its intended use, and its features.
8. Provide information on the device's design, materials, and specifications.
9. Discuss any performance testing or clinical studies conducted on the device.
10. Explain how the device compares to similar products already on the market.
11. Summarize any risk assessments or safety considerations.
12. Include labeling information and instructions for use.
13. Ensure that the summary is clear, concise, and accurate.
14. Proofread the document for any errors or inconsistencies.
15. Submit the completed 510(k) summary along with the required supporting documentation to the FDA.
16. Follow up with the FDA as necessary to address any questions or requests for additional information.

Who needs 510k summary k101907 22?

1. Medical device manufacturers who intend to market a new device that is substantially equivalent to an already legally marketed device.
2. Companies seeking FDA clearance or approval for a medical device that does not qualify for exempt status.
3. Individuals or organizations involved in the development, manufacturing, or distribution of medical devices subject to FDA regulation.
4. Regulatory affairs professionals responsible for preparing and submitting 510(k) applications on behalf of a medical device manufacturer.
5. Healthcare professionals or researchers interested in understanding the regulatory process for medical devices in the United States.

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What is 510k summary k101907 22?

It is a summary of premarket notification 510(k) for a specific medical device.

Who is required to file 510k summary k101907 22?

Medical device manufacturers who are seeking FDA clearance to market their device.

How to fill out 510k summary k101907 22?

The form must be completed with detailed information about the medical device, its intended use, performance data, and comparisons to similar devices on the market.

What is the purpose of 510k summary k101907 22?

The purpose is to demonstrate that the medical device is substantially equivalent to a device that is already legally marketed.

What information must be reported on 510k summary k101907 22?

Information such as device description, intended use, materials, performance data, biocompatibility, sterilization, and software verification.