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K(130274-Page 1 of 5 510(k) SUMMARY: K130274 As required by 21CFR807.92 Oct 2 ELITE SURGICAL SUPPLIES (PTY) LTD Contact detail 510(k) Prepared Name of firm Postal Address Summary Billion Intervertebral

How to fill out 510k summary k130274

How to fill out 510k summary k130274:

1. Review the instructions: Before starting the process, carefully read the instructions provided for filling out the 510k summary k130274. Make sure you understand all the requirements and sections that need to be completed.
2. Gather the necessary information: Collect all the relevant information and documents required to complete the 510k summary k130274. This may include product specifications, testing data, clinical trials results, and any other supporting documentation.
3. Provide accurate product details: In the 510k summary, accurately describe the product for which you are seeking clearance. Mention its intended use, indications, and any specific features or characteristics that distinguish it from similar products.
4. Outline the regulatory pathway: Clearly state the regulatory pathway you are pursuing with the 510k summary k130274. This may involve citing any applicable regulations or standards that you are following in the development and manufacturing of your product.
5. Include testing and evaluation information: Detail any testing or evaluation that has been conducted on the product to ensure its safety and effectiveness. Provide data, results, and analysis to support the claims made in the summary.
6. Discuss any clinical trials: If clinical trials have been conducted, mention the methodology, sample size, and key findings. Emphasize any positive outcomes or insights gained from the trials.
7. Address potential risks: Assess and describe any potential risks associated with the use of the product. Explain the steps taken to minimize these risks and ensure the product's safety for its intended use.

Who needs 510k summary k130274:

1. Medical device manufacturers: Companies involved in the development, manufacturing, or distribution of medical devices may need to fill out the 510k summary k130274. This summary is necessary to seek clearance from the United States Food and Drug Administration (FDA) before marketing a new medical device.
2. Regulatory affairs professionals: Professionals working in the field of regulatory affairs may be responsible for completing the 510k summary k130274 on behalf of their company or clients. They ensure compliance with FDA regulations and guidelines.
3. Quality assurance personnel: Quality assurance professionals play a vital role in ensuring that all the necessary information is accurately included in the 510k summary k130274. They verify that the document meets the required standards and guidelines.

Please note that the specific individuals or organizations needing the 510k summary k130274 may vary depending on the nature of the medical device and the regulatory requirements in different countries or regions. It is essential to consult the relevant regulatory authorities and seek their guidance for specific cases.

For pdfFiller’s FAQs

What is 510k summary k130274?

510k summary k130274 is a summary of a premarket notification submission made to the FDA for a medical device.

Who is required to file 510k summary k130274?

The manufacturer or importer of a medical device is required to file the 510k summary k130274.

How to fill out 510k summary k130274?

The 510k summary k130274 should be filled out following the FDA guidelines for premarket notification submissions.

What is the purpose of 510k summary k130274?

The purpose of 510k summary k130274 is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device.

What information must be reported on 510k summary k130274?

The 510k summary k130274 must include information about the device, its intended use, performance testing, and comparison to predicate devices.

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