Get the free The Assigned 510(k) number is: 91

510(k) SUMMARY 1. Date: 2. Submitter:December 20, 2013, POLYMER THERAPEUTICS, INC. 3040 Post Oak Blvd Ste I 10 Houston, TX 77056 Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F3; Contact

How to fill out form assigned 510k number

How to fill out form assigned 510k number

1. To fill out a form assigned 510k number, follow these steps:
2. Obtain the 510k number from the relevant regulatory agency.
3. Gather all required information and documentation for the form.
4. Start by providing the basic details such as the product name, manufacturer, and contact information.
5. Fill out the specific sections of the form related to the device description, intended use, and indications for use.
6. Include any necessary technical specifications, labeling information, and test results.
7. Provide any additional supporting documentation or references as requested.
8. Review the filled form for accuracy and completeness.
9. Submit the completed form along with any required fees to the regulatory agency.
10. Follow up with the regulatory agency for any additional information or clarification, if needed.
11. Await a response from the regulatory agency regarding the status of the form and the assigned 510k number.

Who needs form assigned 510k number?

1. Any medical device manufacturer who intends to market their device in the United States needs to fill out a form assigned 510k number.
2. The form is required for devices that are substantially equivalent to another legally marketed device (predicate) and typically includes most types of medical devices.
3. Obtaining a 510k number is crucial for medical device companies to demonstrate the safety and effectiveness of their products before they can be commercially distributed in the US market.

For pdfFiller’s FAQs

How can I send form assigned 510k number for eSignature?

To distribute your form assigned 510k number, simply send it to others and receive the eSigned document back instantly. Post or email a PDF that you've notarized online. Doing so requires never leaving your account.

Can I edit form assigned 510k number on an Android device?

Yes, you can. With the pdfFiller mobile app for Android, you can edit, sign, and share form assigned 510k number on your mobile device from any location; only an internet connection is needed. Get the app and start to streamline your document workflow from anywhere.

How do I complete form assigned 510k number on an Android device?

On an Android device, use the pdfFiller mobile app to finish your form assigned 510k number. The program allows you to execute all necessary document management operations, such as adding, editing, and removing text, signing, annotating, and more. You only need a smartphone and an internet connection.

What is form assigned 510k number?

Form assigned 510k number is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file form assigned 510k number?

Manufacturers who intend to market a medical device in the United States are required to file form assigned 510k number.

How to fill out form assigned 510k number?

Form assigned 510k number needs to be filled out with detailed information about the medical device, its intended use, technological characteristics, and performance data compared to a similar legally marketed device.

What is the purpose of form assigned 510k number?

The purpose of form assigned 510k number is to demonstrate that the medical device is substantially equivalent to a legally marketed device and does not pose unreasonable risk to patients.

What information must be reported on form assigned 510k number?

Form assigned 510k number must include information on the device description, proposed indications for use, technological characteristics, performance data, and biocompatibility.