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K13 3077-Page 1 of 5 510(k) Summary (As required by 21 CPU 807.92(a)) JUL 2 8 2014 Applicant and Correspondent Name: Address: Generic Medical International 1910 D Street La Verne, CA 91750 Contact

How to fill out 2 8 2014 510k

How to Fill out a 2 8 2014 510(k) and Who Needs It?

1. Understand the Purpose: The 2 8 2014 510(k) is a form required by the U.S. Food and Drug Administration (FDA) for medical device clearance. It includes information about the device's safety and effectiveness, allowing the FDA to determine if the device is substantially equivalent to a legally marketed device.
2. Gather Relevant Information: Start by collecting all the necessary details about the medical device you are seeking clearance for. This includes technical specifications, intended use, indications for use, labeling, and any clinical data supporting the device's safety and effectiveness.
3. Complete the FDA Form: Access the official FDA website to download the 2 8 2014 510(k) form. Fill out the form accurately and thoroughly, providing all requested information. This includes details about the device, manufacturer, indications for use, performance testing, labeling, and more. Make sure to follow the form's instructions carefully and double-check for any errors or omissions.
4. Prepare a Technical File: Alongside the 2 8 2014 510(k) form, you will need to compile a technical file that supports the safety and efficacy of your medical device. This file should include design documentation, risk assessments, performance testing results, and any clinical data or studies related to the device.
5. Submit the Application: Once the form is completed and the technical file is assembled, submit the 2 8 2014 510(k) application to the FDA. Ensure all supporting documents are included and the application is correctly signed and dated. Check the FDA's website for the most up-to-date submission procedures.

Who Needs a 2 8 2014 510(k)?

1. Medical Device Manufacturers: Any manufacturer planning to market a new medical device that does not qualify for an exemption must submit a 2 8 2014 510(k) application to the FDA. This applies to both domestic and foreign manufacturers.
2. Remanufacturers or Reprocessors: Companies that modify or reprocess existing medical devices to be reintroduced into the market may also need to submit a 2 8 2014 510(k) if the modifications affect the device's safety or effectiveness.
3. Importers: Importers who bring medical devices into the United States from foreign manufacturers are responsible for ensuring the devices comply with FDA regulations. If the imported device requires FDA clearance, the importer should submit a 2 8 2014 510(k) application.
4. Third-Party Review Organizations: Third-party organizations that perform premarket review of medical devices on behalf of the FDA must also follow the 2 8 2014 510(k) submission process.

Remember, it is important to consult the FDA's official guidelines and regulations specific to the 2 8 2014 510(k) process for the most accurate and up-to-date information.

For pdfFiller’s FAQs

What is 2 8 510k summary?

A 510(k) summary is a brief overview of a premarket notification submission.

Who is required to file 2 8 510k summary?

Medical device manufacturers who are seeking FDA clearance to market a new medical device.

How to fill out 2 8 510k summary?

Fill out the 510(k) summary with a concise description of the device, the intended use, and the technological characteristics.

What is the purpose of 2 8 510k summary?

The purpose is to provide a summary of the data and information submitted in a 510(k) application for FDA clearance.

What information must be reported on 2 8 510k summary?

The information reported should include device description, intended use, technological characteristics, and data supporting substantial equivalence.

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