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Aft, an iPad CompanyAxxent Radiation Shield Rigid 510(k)Sunnyvale, California(I A I×Tab 4 510O(k) Summary 2020,1Submitter Soft, an iPad Company Establishment Registration Number: 3005594788 345 Pottery

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How to fill out 510k clearancesfda - us

01

Submit a premarket notification (510(k)) to the FDA.

02

Include detailed information about the device such as its intended use, design, performance testing, and labeling.

03

Provide evidence that the device is substantially equivalent to a legally marketed device.

04

Respond to any requests for additional information or clarification from the FDA.

Who needs 510k clearancesfda - us?

01

Manufacturers of medical devices in the United States who wish to legally market their device and demonstrate its safety and effectiveness.

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What is 510k clearancesfda - us?

The 510k clearancesfda - us is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective.

Who is required to file 510k clearancesfda - us?

Manufacturers of medical devices are required to file 510k clearancesfda - us.

How to fill out 510k clearancesfda - us?

To fill out a 510k clearance, the manufacturer needs to provide information on the device, its intended use, and comparison to a legally marketed device.

What is the purpose of 510k clearancesfda - us?

The purpose of 510k clearancesfda - us is to demonstrate that the device is as safe and effective as a legally marketed device.

What information must be reported on 510k clearancesfda - us?

Information such as device description, intended use, technological characteristics, and performance data must be reported on 510k clearancesfda - us.

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