Get the free 510(k) Number: Date: Page 1 of 2 '2 6 3 510(k) Summary Introduction JUL -12008 This ...

510(k) Number: Date: Page 1 of 2 '2 6 3 510(k) Summary Introduction JUL -12008 This summary is intended to comply with requirements of the SODA and 21CFR 807.92. FDA may make this summary available

How to fill out 510k number date page

How to fill out 510k number date page:

1. Start by entering the 510k number provided by the FDA in the designated field.
2. Next, include the date on which the 510k was issued or received.
3. Provide any additional requested information, such as the expiration date or any amendments made to the 510k.

Who needs 510k number date page:

1. Medical device manufacturers who have obtained FDA clearance or approval for their devices through the 510k process.
2. Regulatory professionals responsible for maintaining accurate records of FDA submissions.
3. Healthcare institutions or providers that need to verify the status and validity of medical devices they use or purchase.

For pdfFiller’s FAQs

How do I make changes in 510k number date page?

The editing procedure is simple with pdfFiller. Open your 510k number date page in the editor. You may also add photos, draw arrows and lines, insert sticky notes and text boxes, and more.

Can I sign the 510k number date page electronically in Chrome?

Yes, you can. With pdfFiller, you not only get a feature-rich PDF editor and fillable form builder but a powerful e-signature solution that you can add directly to your Chrome browser. Using our extension, you can create your legally-binding eSignature by typing, drawing, or capturing a photo of your signature using your webcam. Choose whichever method you prefer and eSign your 510k number date page in minutes.

Can I create an electronic signature for signing my 510k number date page in Gmail?

With pdfFiller's add-on, you may upload, type, or draw a signature in Gmail. You can eSign your 510k number date page and other papers directly in your mailbox with pdfFiller. To preserve signed papers and your personal signatures, create an account.

What is 510k number date page?

The 510k number date page is a form used by medical device manufacturers to report the submission of their 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). It includes important information such as the submission date and the unique 510k number assigned to the device.

Who is required to file 510k number date page?

Medical device manufacturers who are seeking to market a new medical device in the United States are required to file the 510k number date page. This requirement is regulated by the FDA.

How to fill out 510k number date page?

To fill out the 510k number date page, the manufacturer must provide the submission date of their 510(k) premarket notification, the unique 510k number assigned to the device, and any other requested information. The form can be filled out electronically or submitted in paper format.

What is the purpose of 510k number date page?

The purpose of the 510k number date page is to ensure that the FDA has accurate information about the submission of a medical device's 510(k) premarket notification. It helps the FDA track the review process, monitor timelines, and maintain proper documentation of medical devices seeking market clearance.

What information must be reported on 510k number date page?

The 510k number date page requires the reporting of the submission date of the 510(k) premarket notification and the unique 510k number assigned to the device. Additional information may be requested by the FDA, depending on their specific requirements.