Get the free K111387 - 510(k) Premarket Notification - US Food and Drug ...

Medium, Inc. 700 Nickerson Road, Marlborough, MA 01752IQUUTel$1508970 510(K) SUMMARY0099 Fax 5089700119 www.lQuum.comAUGApplicantJQuum, Inc. 700 Nickerson Road Marlborough, MA 0 1752 Tel: 5089700099

How to fill out k111387 - 510k premarket

How to fill out k111387 - 510k premarket

1. To fill out the k111387 - 510k premarket, follow these steps:
2. Gather all necessary information and documentation required for the submission.
3. Begin by filling out the general information section, including the name of the device and the company submitting the application.
4. Provide a detailed description of the device, its intended use, and any predicate devices that it is similar to.
5. Include information on the device's design, components, and materials used in its construction.
6. Provide data on any testing or clinical studies conducted to demonstrate the device's safety and effectiveness.
7. Include labeling information, such as instructions for use, warnings, and contraindications.
8. Provide any additional information or data requested by the FDA related to the device's performance or safety.
9. Review the completed application for accuracy and completeness before submitting it to the FDA.
10. Submit the application electronically through the FDA's electronic submission portal.
11. Monitor the application status and respond promptly to any requests for additional information or clarification from the FDA.
12. Note: It is recommended to consult with regulatory experts or seek professional assistance when filling out the k111387 - 510k premarket to ensure compliance with FDA regulations.

Who needs k111387 - 510k premarket?

1. The k111387 - 510k premarket is required for any company or individual intending to market a class II medical device in the United States.
2. This includes manufacturers, distributors, and importers of medical devices that are not exempt from premarket notification requirements.
3. It is important to note that certain types of medical devices may require different types of premarket submissions, and it is advisable to consult with regulatory experts or the FDA for specific guidance.

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What is k111387 - 510k premarket?

It is a submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file k111387 - 510k premarket?

Manufacturers of new medical devices seeking FDA approval to market their products in the United States are required to file a 510(k) premarket notification.

How to fill out k111387 - 510k premarket?

The 510(k) premarket notification should include information on the device, its intended use, performance data, comparison to similar devices, and any risks associated with the device.

What is the purpose of k111387 - 510k premarket?

The purpose of the 510(k) premarket notification is to demonstrate that the new device is as safe and effective as a legally marketed device with the same intended use.

What information must be reported on k111387 - 510k premarket?

The 510(k) premarket notification must include detailed information on the device, its intended use, materials, design, performance testing, labeling, and any adverse events associated with similar devices.