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510(k) Premarket Notification Submission ABL837 FLEX analyzer with pleural pH RADIO E j07 D 77 Section 5 510(k) Summary DEC 10 2010 1. Submitter Information A. Establishment Registration: 3002807968

How to fill out 510k premarket notification submission

How to fill out 510k premarket notification submission:

1. Gather all necessary information and documentation required for the submission, such as product description, intended use, technological characteristics, and clinical data if applicable.
2. Complete the FDA Form 3601, also known as the Premarket Notification 510(k). Provide accurate and detailed information about the device, including its classification, indications for use, and any previous submissions or clearances.
3. Prepare a concise and comprehensive summary of the device's safety and effectiveness, highlighting any substantial equivalence to legally marketed devices or any differences in technological characteristics.
4. Include a detailed description of the device, its components, and how it is manufactured and sterilized, if applicable. Provide information on any packaging or labeling requirements.
5. Include a thorough summary of any clinical and non-clinical testing, performance testing, and evaluation studies conducted to demonstrate the safety and effectiveness of the device.
6. If applicable, include any unique features or advances in technology that differentiate the device from existing products in the market.
7. Provide any additional information that may be relevant to the review process, such as proposed labeling, software instructions, or any potential risks associated with the device.
8. Ensure all necessary attachments and appendices are included, such as test reports, instructions for use, labeling, and any other supporting documents required by the FDA.
9. Check for completeness and accuracy of all information provided before submitting the 510(k) premarket notification to the FDA.

Who needs 510k premarket notification submission?

1. Medical device manufacturers who intend to introduce a new medical device into the US market typically need to submit a 510(k) premarket notification to the FDA.
2. Manufacturers who intend to make changes to an existing device that could significantly affect its safety or effectiveness may also need to submit a new 510(k) premarket notification.
3. In some cases, the FDA may require a 510(k) premarket notification for a device that is already in the market if it determines that the device is not substantially equivalent to existing legally marketed devices.

Note: It is recommended to consult the FDA's official guidance documents and regulations for accurate and up-to-date information on the process of filling out the 510(k) premarket notification submission.

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What is 510k premarket notification submission?

The 510(k) premarket notification submission is a process used by the U.S. Food and Drug Administration (FDA) to review and clear medical devices for marketing in the United States.

Who is required to file 510k premarket notification submission?

Manufacturers who intend to market a medical device in the United States are required to file a 510(k) premarket notification submission.

How to fill out 510k premarket notification submission?

To fill out a 510(k) premarket notification submission, manufacturers must provide detailed information about the device, including its intended use, design, materials, and performance.

What is the purpose of 510k premarket notification submission?

The purpose of the 510(k) premarket notification submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed device already on the market, in terms of safety and effectiveness.

What information must be reported on 510k premarket notification submission?

The information reported on a 510(k) premarket notification submission includes device descriptions, performance data, labeling, and any clinical data obtained from studies.