Get the free 510(k) U K120398 - accessdata fda

510(k) Summary per 21 CFR 807.92 Page I of4 510(k) U K120398 AUG 162012 5 10(k) SUBMITTER: ESTABLISHMENT REGISTRATION: CONTACT: DATE PREPARED: PROPRIETARY NAME: PANEL: REGULATION NUMBER: CLASSIFICATION:

How to fill out 510k u k120398

How to fill out 510k u k120398:

1. Start by carefully reviewing the instructions provided with the form.
2. Make sure you have all the necessary information and documentation required for the application.
3. Begin by filling out the basic information section of the form, including the device name, manufacturer information, and contact details.
4. Provide a thorough description of the device, including its intended use and any similar devices in the market.
5. Include detailed information about the device's components, materials, and any potential risks or hazards associated with its use.
6. Provide a comprehensive summary of any testing or clinical evaluations conducted on the device, including the results and any relevant data.
7. Clearly outline any modifications or changes made to the device, along with the reason for these modifications.
8. Include a list of any standards or guidelines followed during the development and manufacture of the device.
9. Attach any supporting documentation or test reports that are required for the application.
10. Once all the sections of the form are completed, review the information thoroughly to ensure accuracy and completeness before submitting it.

Who needs 510k u k120398:

1. Medical device manufacturers who are seeking clearance or approval from the relevant regulatory authority for their new medical device.
2. Distributors or importers who intend to market or sell the medical device in a particular country or region.
3. Regulatory consultants or agents who assist medical device manufacturers in the submission and approval process of medical devices.

It is important to note that the specific requirements for obtaining a 510k clearance may vary depending on the regulatory authority and the country in which the device will be marketed. It is always advisable to consult with the relevant regulatory authority or seek professional assistance to ensure accurate and timely submission of the 510k application.

For pdfFiller’s FAQs

What is 510k u k120398?

510k u k120398 is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device.

Who is required to file 510k u k120398?

Manufacturers of medical devices are required to file a 510k submission with the FDA.

How to fill out 510k u k120398?

To fill out a 510k submission, manufacturers must provide detailed information about the new medical device and demonstrate its substantial equivalence to a predicate device.

What is the purpose of 510k u k120398?

The purpose of a 510k submission is to demonstrate that a new medical device is safe and effective for its intended use.

What information must be reported on 510k u k120398?

Information such as device description, intended use, technological characteristics, sterility, biocompatibility, and performance testing must be reported on a 510k submission.

How can I send 510k u k120398 to be eSigned by others?

When you're ready to share your 510k u k120398, you can send it to other people and get the eSigned document back just as quickly. Share your PDF by email, fax, text message, or USPS mail. You can also notarize your PDF on the web. You don't have to leave your account to do this.

How do I complete 510k u k120398 online?

With pdfFiller, you may easily complete and sign 510k u k120398 online. It lets you modify original PDF material, highlight, blackout, erase, and write text anywhere on a page, legally eSign your document, and do a lot more. Create a free account to handle professional papers online.

How do I edit 510k u k120398 in Chrome?

Download and install the pdfFiller Google Chrome Extension to your browser to edit, fill out, and eSign your 510k u k120398, which you can open in the editor with a single click from a Google search page. Fillable documents may be executed from any internet-connected device without leaving Chrome.