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AU102911AG10215 10(k) SUMMARY as required per 807.92© Light Lab Imaging, Inc. One Technology Park Drive West ford, MA 01886Submitter\'s Name and Address:Name, Title, and Telephone Number of Contact:

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How to fill out online 510k summary as

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To fill out the online 510k summary, follow these steps:

02

Log in to the online platform or website where the 510k summary is provided.

03

Enter the required information, such as the device name, manufacturer details, and product code.

04

Upload any necessary supporting documents, such as test reports or clinical data.

05

Review the entered information and make sure all details are accurate.

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Who needs online 510k summary as?

01

The online 510k summary is needed by medical device manufacturers or authorized representatives who want to submit a 510k application to the regulatory authority. It is a required document for the regulatory review process, providing a summary of the safety and effectiveness of the medical device prior to its market approval.

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What is online 510k summary as?

Online 510k summary is an electronic submission that provides a summary of a premarket notification 510k for a medical device.

Who is required to file online 510k summary as?

Manufacturers who intend to market a medical device in the United States are required to file an online 510k summary.

How to fill out online 510k summary as?

Online 510k summary can be filled out electronically through the FDA's online submission portal by providing information about the medical device and its intended use.

What is the purpose of online 510k summary as?

The purpose of online 510k summary is to demonstrate to the FDA that a medical device is substantially equivalent to a legally marketed device.

What information must be reported on online 510k summary as?

Information such as the device description, intended use, performance data, and comparisons to predicate devices must be reported on online 510k summary.

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