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K(1326406.0(1/4)510(K) SUMMARY (PAGE 1 OF 4) Submitter\'s Name and Address:Conformist Inc. 28 Crosby Drive Bedford, MA 01730Establishment Registration Number:3009844603 and 3004153240Date of Summary:August

How to fill out 60 510k summary page

How to fill out 60 510k summary page

1. To fill out the 60 510k summary page, follow these steps:
2. Start by entering the necessary information at the top of the page, such as the 510k number, the medical device's name, and the applicant's information.
3. Provide a concise summary of the device, including its intended use, functionality, and performance characteristics.
4. Include a list of the device components and their respective materials, along with any accessories or attachments that are part of the system.
5. Describe the device's technological features and any unique aspects that differentiate it from similar products in the market.
6. Provide a summary of any clinical data or studies that demonstrate the safety and effectiveness of the device.
7. State any labeling claims made for the device and provide supporting evidence, such as references to scientific literature or regulatory guidelines.
8. Finally, ensure that all the required sections and information have been completed accurately and thoroughly before submitting the 60 510k summary page.

Who needs 60 510k summary page?

1. The 60 510k summary page is required for medical device manufacturers who are seeking FDA clearance to market a new or modified medical device in the United States.
2. It is part of the documentation required for the 510(k) premarket notification process, which allows the FDA to review the device's safety and effectiveness before it can be legally marketed.
3. Therefore, any medical device manufacturer, both domestic and foreign, who wishes to sell their device in the U.S. market needs to submit a 60 510k summary page as part of their 510(k) application.

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What is 60 510k summary page?

The 60 510k summary page is a document that provides a summary of a medical device's safety and effectiveness data submitted to the FDA for premarket notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act.

Who is required to file 60 510k summary page?

Manufacturers of medical devices that are seeking to demonstrate that their device is substantially equivalent to an already marketed device are required to file the 60 510k summary page.

How to fill out 60 510k summary page?

To fill out the 60 510k summary page, manufacturers must provide detailed information about the device, including its intended use, design, performance, labeling, and any testing conducted to support its safety and efficacy.

What is the purpose of 60 510k summary page?

The purpose of the 60 510k summary page is to provide a concise overview of the device's information to regulators, ensuring that essential details are readily available for evaluation of the device's premarket submission.

What information must be reported on 60 510k summary page?

Information reported on the 60 510k summary page must include the device's name, its intended use, reference devices for substantial equivalence, any clinical and non-clinical data, as well as labeling and manufacturing details.