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510(k) SummarySP7721This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.93Submitter:BIOME 3i 4555 Riverside Drive Palm

How to fill out this summary of 510k

How to fill out this summary of 510k

1. To fill out the summary of 510k, follow these steps:
2. Start by entering the name and contact information of the submitter.
3. Provide the appropriate identification number for the device in question.
4. Clearly state the intended use of the device and its technological characteristics.
5. Include detailed information on the device's components, materials, and design.
6. Outline the performance and safety specifications of the device.
7. Describe any testing or clinical data that supports the device's safety and effectiveness.
8. Mention any similar devices on the market and highlight any differences or advantages.
9. Provide a list of any standards or regulations that the device complies with.
10. Include any labeling or instructions for use that will accompany the device.
11. Finally, review the summary for accuracy and completeness before submitting.

Who needs this summary of 510k?

1. The summary of 510k is needed by the following individuals or entities:
2. - Medical device manufacturers planning to introduce a new device to the market.
3. - Regulatory affairs specialists responsible for preparing and submitting the 510k application.
4. - Testing laboratories or researchers involved in conducting studies on medical devices.
5. - Regulatory authorities who review and evaluate the safety and effectiveness of medical devices.
6. - Healthcare professionals who rely on accurate and comprehensive information to make informed decisions.

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What is this summary of 510k?

This summary of 510k is a document required by the FDA for medical device manufacturers who are seeking clearance to market their device.

Who is required to file this summary of 510k?

Medical device manufacturers are required to file this summary of 510k with the FDA.

How to fill out this summary of 510k?

The summary of 510k must be filled out by providing detailed information about the safety and effectiveness of the medical device being submitted for clearance.

What is the purpose of this summary of 510k?

The purpose of this summary of 510k is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device.

What information must be reported on this summary of 510k?

The summary of 510k must include information about the device, its intended use, the technological characteristics, and any clinical data supporting its safety and effectiveness.