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51 0(k) Premarket NotificationAesculap Sterilcontainer S for PRO 1 & PRO Plus Systemic?size Page 1of 2 B.510(k) SUMMARY (as required by 21 CFR 807.92) Secular Sterilcontainer S for PRO 1 and PRO 1

How to fill out 51 0k premarket notification

How to fill out 51 0k premarket notification

1. Obtain the necessary information and documentation for your medical device.
2. Determine the classification of your device. Classify it as Class II or Class III.
3. Prepare a Pre-market Notification (510(k)) submission.
4. Include a cover letter with important details about your device.
5. Complete and submit Form FDA 3514.
6. Prepare a Summary of Safety and Effectiveness Data (SSED).
7. Compile information on predicate devices that demonstrate substantial equivalence.
8. Prepare a Device Description Section.
9. Include labeling information and any applicable standards.
10. Pay the required user fee and submit the 510(k) submission to the FDA.
11. Respond promptly to any requests for additional information or clarification from the FDA.
12. Await the FDA's decision on your 510(k) submission.

Who needs 51 0k premarket notification?

1. Any manufacturer or distributor who wants to introduce a new medical device into the US market.
2. Companies that intend to modify an existing device or change its intended use may also require a 510(k) premarket notification.
3. Additionally, foreign manufacturers who want to export medical devices to the US may need to submit a 510(k) notification.
4. It is highly recommended to seek professional guidance and consult the FDA's regulations for specific requirements.

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What is 510k premarket notification?

A 510k premarket notification 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 510k premarket notification?

Manufacturers of medical devices are required to file a 510k premarket notification before marketing their new device.

How to fill out 510k premarket notification?

To fill out a 510k premarket notification, manufacturers need to provide detailed information about the new device's intended use, design, materials, performance, and other relevant aspects.

What is the purpose of 510k premarket notification?

The purpose of 510k premarket notification is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device.

What information must be reported on 510k premarket notification?

The 510k premarket notification must include information on the device's design, intended use, performance data, comparisons to predicate devices, and any labeling or instructions for use.